| Primary Device ID | 00858816006071 |
| NIH Device Record Key | aafe5c4d-be26-49a0-b991-845b3bf516ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZipE Knotless Tissue Repair and attachment devices |
| Version Model Number | c7-50160-ss |
| Catalog Number | 71 |
| 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 | 00858816006071 [Primary] |
| LRY | Punch, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
Moist Heat or Steam Sterilization
[00858816006071]
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 |
| 00858816006064 | Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capt |
| 00858816006071 | ZipE® resusable medical grade stainless steel punch tool |