Primary Device ID | 00810111220606 |
NIH Device Record Key | 4e1bce87-b6c7-4b6b-a268-2e554688a6c7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Osteotome |
Version Model Number | 1405-2626 |
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 | true |
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 | 00810111220606 [Primary] |
HWM | Osteotome |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
[00810111220606]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-08 |
Device Publish Date | 2022-11-30 |
00853114006334 | TriTome™ Triple-Edge Release Instrument |
00810111221009 | Osteotome |
00810111220910 | Osteotome |
00810111220903 | Osteotome |
00810111220606 | Hooked Osteotome |
00810111220590 | Straight Osteotome |
00810111221641 | Hooked Osteotome |
00810111221634 | Square Osteotome |