| Primary Device ID | 10705031062238 |
| NIH Device Record Key | ba7b6d6c-13b4-47c9-8e28-a38678261c2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GYNECARE TVT |
| Version Model Number | 810051 |
| Catalog Number | 810051 |
| Company DUNS | 480920383 |
| Company Name | Ethicon Sàrl |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031062238 [Primary] |
| KOA | SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
[10705031062238]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-20 |
| Device Publish Date | 2015-09-23 |
| 10705031062306 | Obturator system, Tension-free support for incontinence |
| 10705031062290 | Tension-free support, Blue Polypropylene Mesh Tape |
| 10705031062283 | Abdominal Guides |
| 10705031062245 | Reusable Rigid Catheter Guide |
| 10705031062238 | Reusable Introducer |
| 10705031000346 | Tension-free support for incontinence |
| 10705031000322 | Tension-free support, Blue Polypropylene Mesh Tape |