| Primary Device ID | 00841436104166 |
| NIH Device Record Key | 52edc161-9718-4399-9742-3509f378073e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgi-Boot Transducer Cover |
| Version Model Number | 610-797, 610-797-5 |
| Catalog Number | 610-797, 610-797-5 |
| 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 | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 Inch |
| Length | 96 Inch |
| Width | 6 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 | 00841436104159 [Package] Contains: 10841436104163 Package: [5 Units] In Commercial Distribution |
| GS1 | 00841436104166 [Package] Contains: 10841436104163 Package: [12 Units] In Commercial Distribution |
| GS1 | 10841436104163 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
Ethylene Oxide
[00841436104166]
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 |
| 00841436110372 | Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGu |
| 00841436104166 | Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGu |