Primary Device ID | 00810111223416 |
NIH Device Record Key | cd231e6b-eb2f-4768-b4c9-848681239dc2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Depth gauge countersink |
Version Model Number | 02-00246 |
Company DUNS | 054808082 |
Company Name | Treace Medical Concepts, Inc. |
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 | false |
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 | 00810111223416 [Primary] |
HWW | Countersink |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
[00810111223416]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-27 |
Device Publish Date | 2024-11-19 |
00810111224499 - Drill Guide | 2025-09-22 Drill Guide and Template |
00810111223904 - Targeting Guide | 2025-09-04 Trajectory Guide |
00810111223911 - Targeting Guide | 2025-09-04 Guide Targeter |
00810111223928 - Targeting Guide | 2025-09-04 Guide Body |
00810111223935 - Cut Guide | 2025-09-04 Cut Guide |
00810111225076 - Drill Tack | 2025-09-04 2.9MM Tack |
00810111223874 - K-wire Sleeve | 2025-09-03 4mm Short Sleeve |
00810111223881 - K-wire Sleeve | 2025-09-03 3mm Long Sleeve |