Primary Device ID | 00860794002631 |
NIH Device Record Key | 628686ed-94c8-4b4e-894f-5264a7c94667 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Champion Suture Passer Ratchet Humpback Capture |
Version Model Number | 3910-900-089 |
Company DUNS | 117021487 |
Company Name | Lincotek Medical 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 | 00860794002631 [Primary] |
MDM | Instrument, Manual, Surgical, General Use |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
[00860794002631]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-10 |
Device Publish Date | 2024-01-02 |
00860794002679 - Versipass Suture Passer Needle | 2024-10-25 Suture passer needle for the Versipass Suture Passer |
00860794002600 - Champion Suture Passer Ratchet Straight | 2024-01-10 Champion Suture Passer Ratchet Straight |
00860794002617 - Champion Suture Passer Ratchet Humpback | 2024-01-10 Champion Suture Passer Ratchet Humpback |
00860794002624 - Champion Suture Passer Ratchet Straight Capture | 2024-01-10 Champion Suture Passer Ratchet Straight Capture |
00860794002631 - Champion Suture Passer Ratchet Humpback Capture | 2024-01-10Champion Suture Passer Ratchet Humpback Capture |
00860794002631 - Champion Suture Passer Ratchet Humpback Capture | 2024-01-10 Champion Suture Passer Ratchet Humpback Capture |
00860794002655 - Champion Suture Passer Needle | 2023-12-26 Champion Passer Needle - single needle |
00860794002662 - Versipass Suture Passer | 2023-12-20 The VersiPass Suture Passer instrument is a reusable manual surgical instrument used to pass sutures for arthroscopic and open r |