Primary Device ID | 00810111222860 |
NIH Device Record Key | a38136ce-d3a4-4327-8b2c-0c2277a3307e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Elevator |
Version Model Number | 02-00207 |
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 | 00810111222860 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
[00810111222860]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-08 |
Device Publish Date | 2024-10-31 |
00810111224512 - Saw Blade | 2025-05-16 FeatherRasp - ZMS |
00810111224482 - Scalpel | 2025-05-14 MTP Release Instrument |
00810111224505 - Saw Blade | 2025-05-14 FeatherRasp - SM |
00810111224321 - Reamer | 2025-05-02 18mm cup reamer |
00810111224338 - Reamer | 2025-05-02 18mm cone reamer |
00810111224345 - Reamer | 2025-05-02 21mm cup reamer |
00810111224352 - Reamer | 2025-05-02 21mm cone reamer |
00810111224369 - Reamer | 2025-05-02 23mm cup reamer |