| Primary Device ID | 00810111222754 |
| NIH Device Record Key | bf12d8f4-0b4e-4168-b116-b817043c3b68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Wire Sleeve |
| Version Model Number | 02-00196 |
| 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 | 00810111222754 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
[00810111222754]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-19 |
| 00810111222754 | K-Wire Sleeve |
| 00810111224567 | 3mm Short Sleeve |
| 00810111223898 | 4mm Long Sleeve |
| 00810111223881 | 3mm Long Sleeve |
| 00810111223874 | 4mm Short Sleeve |