Primary Device ID | 00810111222815 |
NIH Device Record Key | 590b9cb1-30a4-4c02-ae05-d8fa4603cc03 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cut Guide |
Version Model Number | 02-00143 |
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 | 00810111222815 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
[00810111222815]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-19 |
Device Publish Date | 2024-04-11 |
00853114006990 | lesser TMT cut guide |
00853114006976 | lesser TMT cut guide |
00853114006846 | Cut Guide - platinum |
00853114006839 | MIS cut guide - gold |
00853114006822 | cut guide low angle (short) |
00853114006815 | cut guide low angle - gold |
00853114006761 | cut guide |
00853114006563 | rotational cut guide |
00853114006549 | cut guide |
00853114006532 | cut guide |
00810111221368 | lesser TMT cut guide |
00810111221351 | lesser TMT cut guide |
00810111221122 | Cut Guide |
00810111221115 | Cut Guide |
00810111221108 | Cut Guide |
00810111220484 | Low pro cut guide |
00810111220477 | low pro cut guide |
00810111220460 | low pro cut guide |
00810111220453 | low pro cut guide |
00810111220446 | low pro cut guide |
00810111220439 | low pro cut guide |
00810111220422 | low pro cut guide |
00810111220415 | cut guide - double |
00810111220361 | cut guide |
00810111220347 | lesser TMT cut guide medium |
00810111220330 | lesser TMT cut guide large |
00810111220323 | lesser TMT cut guide medium |
00810111220316 | lesser TMT cut guide small |
00810111220255 | cut guide |
00810111220583 | Cut Guide |
00810111222068 | MTA Stepped Cut Guide |
00810111222051 | MTA Stepped Cut Guide |
00810111222815 | STEPPED INLINE CUT GUIDE, LARGE |
00810111222808 | STEPPED INLINE CUT GUIDE, MEDIUM |
00810111222792 | STEPPED INLINE CUT GUIDE, SMALL |
00810111222778 | Cut Guide |
00810111222662 | Single Slot Cut Guide |