ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM 314-15-14D

GUDID 07899258656007

ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID07899258656007
NIH Device Record Key15782d8e-d7cb-46e6-a761-a21ae4d339e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM
Version Model NumberANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PL
Catalog Number314-15-14D
Company DUNS900865213
Company NameGM DOS REIS INDUSTRIA E COMERCIO LTDA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107899258656007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


[07899258656007]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-10
Device Publish Date2024-12-02

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