OFFSET ACETABULAR REAMER DRIVER HANDLE 481100560

GUDID 07630055301819

Offset Acetabular Reamer Driver - handle component accessory for use with Offset Reamer Handle assemblies

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055301819
NIH Device Record Keyfd72fb56-efac-400d-8db9-b75c4168488f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOFFSET ACETABULAR REAMER DRIVER HANDLE
Version Model Number481100560
Catalog Number481100560
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
GS107630055301819 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

Moist Heat or Steam Sterilization


[07630055301819]

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 [OFFSET ACETABULAR REAMER DRIVER HANDLE]

07630055301819Offset Acetabular Reamer Driver - handle component accessory for use with Offset Reamer Handle a
07630055306623Silicone Handle accessory for Offset Reamer Handle

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