| Primary Device ID | 00860794002624 |
| NIH Device Record Key | 1a25f1a4-6d5a-4564-bccd-90b9984f9592 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Champion Suture Passer Ratchet Straight Capture |
| Version Model Number | 3910-900-088 |
| 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 | 00860794002624 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
Moist Heat or Steam Sterilization
[00860794002624]
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 | 2024-01-10Champion Suture Passer Ratchet Straight Capture |
| 00860794002624 - Champion Suture Passer Ratchet Straight Capture | 2024-01-10 Champion Suture Passer Ratchet Straight Capture |
| 00860794002631 - Champion Suture Passer Ratchet Humpback Capture | 2024-01-10 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 |