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 |