| Primary Device ID | 00858816006088 |
| NIH Device Record Key | f4cc1738-aaec-462a-baff-35c35a8df815 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ziptek knotless tissue repair and attachment devices |
| Version Model Number | B56-635-S_D |
| Catalog Number | 88 |
| Company DUNS | 035237962 |
| Company Name | ZIPTEK LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858816006088 [Primary] |
| LRZ | Screwdriver, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
[00858816006088]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-29 |
| Device Publish Date | 2024-07-19 |
| 00858816006101 | Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr u |
| 00858816006088 | Ziptek small driver/handle assembly medical grade stainless steel for 4.5mm screw insertion and |