2 Hole Plate

GUDID 00810028397071

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810028397071
NIH Device Record Keyed506fa6-b20a-406b-8b27-5ae3d4fcb9cc
Commercial Distribution StatusIn Commercial Distribution
Brand Name2 Hole Plate
Version Model NumberDNE-2-PL
Company DUNS601306413
Company NameMedshape, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028397071 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


[00810028397071]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-09
Device Publish Date2024-05-31

On-Brand Devices [2 Hole Plate]

00810028396302DNE-2-PL
00810028397071DNE-2-PL

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