Offset Reamer Handle - Large AO - Dual Coupling 50244501

GUDID 07630055303929

Offset Reamer Handle for hip arthroplasty

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055303929
NIH Device Record Keydd19f9f4-b863-4f17-b512-ceb4cdca4854
Commercial Distribution StatusIn Commercial Distribution
Brand NameOffset Reamer Handle - Large AO - Dual Coupling
Version Model Number50244501
Catalog Number50244501
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
GS107630055303929 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


[07630055303929]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-13
Device Publish Date2021-12-03

On-Brand Devices [Offset Reamer Handle - Large AO - Dual Coupling]

07630055301376Offset Reamer Handle - Large AO - Dual Coupling
07630055301352Offset Reamer Handle - Large AO - Dual Coupling
07630055302946Offset Reamer Handle for hip arthroplasty
07630055303028Offset Reamer Handle for hip arthroplasty
07630055302939Offset Reamer Handle for hip arthroplasty
07630055303929Offset Reamer Handle for hip arthroplasty
07630055304216Offset Reamer Handle for hip arthroplasty

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