Situate VPK-0448C-F
GUDID 20884521701219
Vaginal Packing - RF and X-ray Detectable Folded
Covidien LP
Radiopaque woven surgical sponge| Primary Device ID | 20884521701219 |
| NIH Device Record Key | 730000c7-aa15-45b0-8b2a-122a99f40e07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Situate |
| Version Model Number | VPK-0448C-F |
| Catalog Number | VPK-0448C-F |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Device Size Text, specify | 0 |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
| Width | 4 Inch |
| Length | 48 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry; |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521701212 [Primary] |
| GS1 | 20884521701219 [Package] Contains: 10884521701212 Package: CASE [150 Units] In Commercial Distribution |
FDA Product Code
| GDY | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-08-24 |
| Device Publish Date | 2018-09-26 |
On-Brand Devices [Situate]
| 30884521722259 | Sterile Drape For use with Situate Room Scanner; Caution: For Manufacturing, Processing or Repac |
| 20884521700779 | Gauze-RF and X-ray Detectable USP Type VII, 8 Ply. Caution: For Manufacturing, Processing or Rep |
| 20884521709888 | OR Towel - RF and X-ray Detectable Green. Caution: For Manufacturing, Processing or Repacking. |
| 20884521701066 | OR Towel -RF and X-ray Detectable White. Caution: For Manufacturing, Processing or Repacking. |
| 20884521701059 | OR Towel -RF and X-ray Detectable Blue. Caution: For Manufacturing, Processing or Repacking. |
| 10884521705319 | Delivery Console 200X |
| 10884521705296 | Delivery Console 200LD-V |
| 20884521700724 | Room Scanner For use with the Situate Detection Console 200X |
| 10884521700703 | Detection Console 200X |
| 10884521700666 | Delivery Scanner For use with Situate Delivery Console 200LD-V |
| 10884521700659 | Delivery Console 200LD-V |
| 10884521700642 | Body Scanner Lite For use with the Situate Detection Console 200E and Console 200X |
| 20884521700601 | Gauze - RF and X-ray Detectable USP Type VII, 16 Ply |
| 10884521709874 | Sterile Drape For use with Situate Room Scanner |
| 20884521700687 | Sterile Drape For use with Situate Extremity Scanner and Delivery Scanner |
| 20884521701165 | Tonsil Sponge - RF and X-ray Detectable Tape Strung - Cotton Filled |
| 20884521700793 | Gauze-RF and X-ray Detectable USP Type VII, 12 Ply. Caution: For Manufacturing, Processing or Re |
| 20884521721767 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521709833 | OR Towel - RF and X-ray Detectable Green |
| 20884521706948 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521706931 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521706924 | Laparotomy Sponge-RF and X-ray Detectable Unwashed. Caution: For Manufacturing, Processing or Re |
| 20884521706917 | Laparotomy Sponge-RF and X-ray Detectable Ring. Caution: For Manufacturing, Processing or Repack |
| 20884521706900 | Laparotomy Sponge-RF and X-ray Detectable No Loop. Caution: For Manufacturing, Processing or Rep |
| 20884521706894 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521706887 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521706870 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521706863 | Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking. |
| 20884521701233 | Vaginal Packing - RF and X-ray Detectable Folded |
| 20884521701226 | Vaginal Packing - RF and X-ray Detectable Folded |
| 20884521701219 | Vaginal Packing - RF and X-ray Detectable Folded |
| 20884521701202 | Vaginal Packing - RF and X-ray Detectable Folded |
| 20884521701196 | Vaginal Packing - RF and X-ray Detectable Roll |
| 20884521701189 | Vaginal Packing - RF and X-ray Detectable Folded |
| 20884521701172 | Vaginal Packing - RF and X-ray Detectable Roll |
| 20884521701158 | Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled |
| 20884521701141 | Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled |
| 20884521701134 | Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled |
| 20884521701127 | Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled |
| 20884521701110 | Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled |
| 20884521701103 | Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled |
| 20884521701097 | Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled |
| 20884521701080 | Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled |
| 20884521701073 | Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled |
| 20884521701042 | OR Towel - RF and X-ray Detectable White |
| 20884521701035 | OR Towel -RF and X-ray Detectable Blue |
| 20884521701028 | Perineal Packing - RF and X-ray Detectable Roll |
| 20884521701011 | Perineal Packing - RF and X-ray Detectable Roll |
| 20884521701004 | Laparotomy Sponge - RF and X-ray Detectable Pre-washed |
| 20884521700991 | Laparotomy Sponge - RF and X-ray Detectable Pre-washed |
Trademark Results [Situate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SITUATE 88381342 not registered Live/Pending |
Covidien LP 2019-04-11 |
 SITUATE 86768303 not registered Live/Pending |
Covidien LP 2015-09-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.