Half pin - 3 x 100mm with 30mm thread

GUDID 00810028395855

Medshape, Inc.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00810028395855
NIH Device Record Key1324beec-24c2-4917-9f4c-12e6bc6e76c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHalf pin - 3 x 100mm with 30mm thread
Version Model NumberDNE-310030
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
GS100810028395855 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


[00810028395855]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-17
Device Publish Date2024-07-09

Devices Manufactured by Medshape, Inc.

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M9701000042450 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 4.5MM
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M97012000250200 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 20MM
M97012000250220 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 22.5MM

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