Offset reamer handle - Hudson motor shaft 50244508

GUDID 07630055304414

Offset Reamer Handle power coupling accessory

Incipio Devices SA

Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor
Primary Device ID07630055304414
NIH Device Record Key50251cb8-afe4-4088-b9c8-1a569f21c1e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOffset reamer handle - Hudson motor shaft
Version Model Number50244508
Catalog Number50244508
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
GS107630055304414 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


[07630055304414]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-03

Devices Manufactured by Incipio Devices SA

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07630055304780 - Offset Cup Impactor - 3/8-24 interface2024-03-26 Offset Cup Impactor for hip arthroplasty
07630055304933 - Positioning handle - M10x1.5 interface2024-03-20 Positioning handle assembly accessory for offset cup impactor M10x1.5 interface
07630055305107 - Offset Cup Impactor - M10x1.5 interface2024-03-20 Offset Cup Impactor for hip arthroplasty
07630055305190 - Offset Reamer Handle - Handle2024-02-29 Handle accessory for offset reamer handles
07630055305206 - Offset Reamer Handle - Body2024-02-29 Body accessory for offset reamer handles
07630055305213 - Offset reamer handle - Stryker Z/H motor shaft2024-02-29 Offset Reamer Handle power coupling accessory

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