Primary Device ID | 00810111221733 |
NIH Device Record Key | dce24df9-f1fe-4c91-9dba-0a9a2903a6e7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Drill Guide |
Version Model Number | 02-00104 |
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 | 00810111221733 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111221733]
Moist Heat or Steam Sterilization
[00810111221733]
Moist Heat or Steam Sterilization
[00810111221733]
Moist Heat or Steam Sterilization
[00810111221733]
Moist Heat or Steam Sterilization
[00810111221733]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-18 |
Device Publish Date | 2024-07-10 |
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