High Offset Reamer Handle - Stryker Z/H Tri-coupling 50242012

GUDID 07630055306319

50° Offset Reamer Handle for hip arthroplasty

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055306319
NIH Device Record Key64a23665-4886-43e8-8c14-c0eca1b2294c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh Offset Reamer Handle - Stryker Z/H Tri-coupling
Version Model Number1440-4010
Catalog Number50242012
Company DUNS485098284
Company NameIncipio Devices SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS107630055306319 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


[07630055306319]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-08
Device Publish Date2025-11-28

On-Brand Devices [High Offset Reamer Handle - Stryker Z/H Tri-coupling]

0763005530001050° Offset Reamer Handle for hip arthroplasty
0763005530631950° Offset Reamer Handle for hip arthroplasty

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