Nanoplasty System

GUDID 00810111222884

Inserter

Treace Medical Concepts, Inc.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810111222884
NIH Device Record Key73a43cae-dee2-44ac-bc21-7dc1b2697aae
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoplasty System
Version Model Number02-00198
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111222884 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


[00810111222884]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

On-Brand Devices [Nanoplasty System]

00810111222525Bicortical Screw Pack
00810111222471Loading Block
00810111222464Bunion Correction Implants
00810111222457Inserter
00810111222426Drill Guide
00810111222402Drill Guide
00810111222532Rotational Guide
00810111222907Rotation Guide Base
00810111222884Inserter
00810111222914Rotation Guide Extension
00810111222891Drill Guide
008101112224191st Met Inserter Draw Bar

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