Wrench - Pipe

GUDID 00810028397866

Medshape, Inc.

External orthopaedic fixation system, reusable
Primary Device ID00810028397866
NIH Device Record Key9fc83035-08a8-4332-bb65-68366fd94538
Commercial Distribution StatusIn Commercial Distribution
Brand NameWrench - Pipe
Version Model NumberDNE-1000-PW
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
GS100810028397866 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

Moist Heat or Steam Sterilization


[00810028397866]

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.

M9701000032250 - Morphix XT2025-07-29 MORPHIX 2.5mm x 7mm Anchor with two USP
M9701000032350 - Morphix XT2025-07-29 MORPHIX 3.5mm x 8mm Anchor with two USP
M9701000032450 - Morphix XT2025-07-29 MORPHIX 4.5mm x 9mm Anchor with two USP
M9701000041250 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 2.5MM
M9701000042450 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 4.5MM
M9701000042550 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 5.5MM
M97012000250200 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 20MM
M97012000250220 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 22.5MM

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