| Primary Device ID | 00841436104180 |
| NIH Device Record Key | 458e478f-7d00-4d9f-8089-7f70bee4741b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgi-Tip Transducer Cover |
| Version Model Number | 610-834 |
| Catalog Number | 610-834 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Length | 96 Inch |
| Width | 8 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436104180 [Package] Contains: 10841436104187 Package: [12 Units] In Commercial Distribution |
| GS1 | 10841436104187 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
[00841436104180]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2017-08-22 |
| 00841436110365 | Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ |
| 00841436110358 | Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ |
| 00841436110341 | Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (9cm) NeoGuard™ |
| 00841436104180 | Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ |
| 00841436104173 | Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ |
| 00841436101929 | Sterile (15.2 x 244cm) polyethylene accordion-folded cover with attached (3cm) NeoGuard™ Tip |