Primary Device ID | 00810111223393 |
NIH Device Record Key | 67a82ea7-5e3a-4e0b-9e73-13b865510ba1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Drill Guide |
Version Model Number | 02-00226 |
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 | 00810111223393 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
Moist Heat or Steam Sterilization
[00810111223393]
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 |
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00810111221535 | Staple Drill Guide |
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00810111221719 | Drill Guide and Template |
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00810111223591 | Drill Guide - 15.5MM |