55 DEGREE OFFSET ACETABULAR REAMER DRIVER BODY 481100575

GUDID 07630055301833

Offset Acetabular Reamer Driver - body component accessory for use with 55° Angled Reamer Handle assembly

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055301833
NIH Device Record Keyea61a53b-20e1-4106-a4c3-3a88b7a1bb70
Commercial Distribution StatusIn Commercial Distribution
Brand Name55 DEGREE OFFSET ACETABULAR REAMER DRIVER BODY
Version Model Number481100575
Catalog Number481100575
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
GS107630055301833 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


[07630055301833]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

On-Brand Devices [55 DEGREE OFFSET ACETABULAR REAMER DRIVER BODY]

07630055301833Offset Acetabular Reamer Driver - body component accessory for use with 55° Angled Reamer Handl
07630055306647Body Assembly accessory for 55° Angled Reamer Handle

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