Primary Device ID | 00810111223911 |
NIH Device Record Key | 5309b4be-6d8c-4fd9-9cab-86dcf9f07d9c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Targeting Guide |
Version Model Number | 02-00291 |
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 | 00810111223911 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
[00810111223911]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-04 |
Device Publish Date | 2025-08-27 |
00810111223928 | Guide Body |
00810111223911 | Guide Targeter |
00810111223904 | Trajectory Guide |