Offset reamer handle - Stryker Z/H - Tri coupling 50244512

GUDID 07630055305800

30° Offset Reamer Handle for hip arthroplasty

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055305800
NIH Device Record Keycf6a607c-85aa-4db5-8e5c-5808a173716c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOffset reamer handle - Stryker Z/H - Tri coupling
Version Model Number50244512
Catalog Number50244512
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
GS107630055305800 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

Moist Heat or Steam Sterilization


[07630055305800]

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 [Offset reamer handle - Stryker Z/H - Tri coupling]

07630055303066Offset Reamer Handle for hip arthroplasty
07630055304698Offset Reamer Handle for hip arthroplasty
0763005530580030° Offset Reamer Handle for hip arthroplasty

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.