AO T Handle - Red

GUDID 00810028397705

Medshape, Inc.

External orthopaedic fixation system, reusable
Primary Device ID00810028397705
NIH Device Record Keybe9c1f94-f110-43f8-a78a-e90eb2890d80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAO T Handle - Red
Version Model NumberDNE-9000-TH-AO
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028397705 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

Moist Heat or Steam Sterilization


[00810028397705]

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 [AO T Handle - Red]

00850062461703DNE-9000-TH-AO
00810028397705DNE-9000-TH-AO

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