Primary Device ID | 00810111221665 |
NIH Device Record Key | 202e9618-6247-4b02-9d38-c6c9971626e0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | cut guide, fulcrum, seeker |
Version Model Number | 02-00095 |
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 | 00810111221665 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
[00810111221665]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-18 |
Device Publish Date | 2023-05-10 |
00810111220279 | all in one SS Right |
00810111220262 | all in one SS left |
00810111220231 | all in one |
00810111220224 | all in one |
00810111220217 | all in one |
00810111220200 | all in one |
00810111220194 | all in one SS right |
00810111220187 | all in one SS left |
00810111220538 | Mini 3 in 1 Left |
00810111220521 | Mini 3 in 1 Right |
00810111221665 | Mini 3 in 1 Right |
00810111221658 | Mini 3 in 1 Left |