GMReis Ankle Plating System 106-40-21-42

GUDID 07899258623559

MINI CANNULATED COMPRESSION SCREW PARTIAL LONG THREAD Ø 4.0X21X42MM

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic bone screw (non-sliding)
Primary Device ID07899258623559
NIH Device Record Keye2fecf53-7afa-4274-8ea9-c35006f5c9b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMReis Ankle Plating System
Version Model NumberMINI CANNULATED COMPRESSION SCREW PARTIAL LONG THR
Catalog Number106-40-21-42
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
GS107899258623559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

[07899258623559]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-11
Device Publish Date2024-12-03

On-Brand Devices [GMReis Ankle Plating System]

07899258656076ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 10 HOLES 2.7/3.5MM
07899258656069ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 12 HOLES 2.7/3.5MM
07899258656052ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 18 HOLES 2.7/3.5MM
07899258656045ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 18 HOLES 2.7/3.5MM
07899258656038ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 16 HOLES 2.7/3.5MM
07899258656021ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 16 HOLES 2.7/3.5MM
07899258656014ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 14 HOLES 2.7/3.5MM
07899258655994ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 12 HOLES 2.7/3.5MM
07899258655987ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 12 HOLES 2.7/3.5MM
07899258655970ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 10 HOLES 2.7/3.5MM
07899258655925ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 16 HOLES 2.7/3.5MM
07899258655918ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 16 HOLES 2.7/3.5MM
07899258655901ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 14 HOLES 2.7/3.5MM
07899258655895ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 12 HOLES 2.7/3.5MM
07899258655857ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 08 HOLES 2.7/3.5MM
07899258655840ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 08 HOLES 2.7/3.5MM
07899258655833ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 06 HOLES 2.7/3.5MM
07899258655826ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 06 HOLES 2.7/3.5MM
07899258655819ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE LEFT 04 HOLES 2.7/3.5MM
07899258655802ANATOMICAL ANTEROLATERAL TIBIA DISTAL VERSALOCK PLATE RIGHT 04 HOLES 2.7/3.5MM
07899258655796ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 14 HOLES 2.7/3.5MM
07899258655789ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 08 HOLES 2.7/3.5MM
07899258655772ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 04 HOLES 2.7/3.5MM
07899258655765ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 13 HOLES - 2.7/3.5
07899258655758VERSALOCK PLATE POSTERIOR MALLEOLUS T 04 HOLES 2.7MM
07899258655574VERSALOCK PLATE POSTERIOR MALLEOLUS T 03 HOLES 2.7MM
07899258655567ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 10 HOLES 2.7/3.5MM
07899258655550ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 10 HOLES 2.7/3.5MM
07899258655543ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 08 HOLES 2.7/3.5MM
07899258655536ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 06 HOLES 2.7/3.5MM
07899258655529ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE RIGHT 06 HOLES 2.7/3.5MM
07899258655512ANATOMICAL MEDIAL TIBIA DISTAL VERSALOCK PLATE LEFT 04 HOLES 2.7/3.5MM
07899258655505VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 07 HOLES 2.7/3.5MM
07899258655499VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 05 HOLES 2.7/3.5MM
07899258655482VERSALOCK PLATE DISTAL HOOK OF MEDIAL TIBIA 03 HOLES 2.7/3.5MM
07899258655475VERSALOCK VERSATILE PLATE 10 HOLES 3.5MM
07899258655468VERSALOCK VERSATILE PLATE 08 HOLES 3.5MM
07899258655451VERSALOCK VERSATILE PLATE 07 HOLES 3.5MM
07899258655444ANATOMICAL FIBULA VERSALOCK PLATE LEFT 15 HOLES - 2.7/3.5
07899258655437ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 15 HOLES - 2.7/3.5
07899258655420ANATOMICAL FIBULA VERSALOCK PLATE LEFT 13 HOLES - 2.7/3.5
07899258655413ANATOMICAL FIBULA VERSALOCK PLATE LEFT 11 HOLES - 2.7/3.5
07899258655406ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 11 HOLES - 2.7/3.5
07899258655390ANATOMICAL FIBULA VERSALOCK PLATE LEFT 09 HOLES - 2.7/3.5
07899258655383ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 09 HOLES - 2.7/3.5
07899258655345ANATOMICAL FIBULA VERSALOCK PLATE LEFT 05 HOLES - 2.7/3.5
07899258655284ANATOMICAL FIBULA VERSALOCK PLATE RIGHT 07 HOLES - 2.7/3.5
07899258655260VERSALOCK PLATE DISTAL FIBULA HOOK 07 HOLES 2.7/3.5MM
07899258655253VERSALOCK PLATE DISTAL FIBULA HOOK 05 HOLES 2.7/3.5MM
07899258655246VERSALOCK PLATE DISTAL FIBULA HOOK 03 HOLES 2.7/3.5MM
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