50° Offset reamer handle - Large AO - Dual Coupling 50242001

GUDID 07630055306265

50° Offset Reamer Handle for hip arthroplasty

Incipio Devices SA

Surgical power tool adaptor
Primary Device ID07630055306265
NIH Device Record Key0bae9713-2145-4ba7-8311-39c902730a16
Commercial Distribution StatusIn Commercial Distribution
Brand Name50° Offset reamer handle - Large AO - Dual Coupling
Version Model Number50242001
Catalog Number50242001
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
GS107630055306265 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

Moist Heat or Steam Sterilization


[07630055306265]

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

Devices Manufactured by Incipio Devices SA

07630055306968 - Offset reamer handle - large AO - Dual Coupling2026-01-08 30° Offset Reamer Handle for hip arthroplasty
07630055306975 - Straight reamer handle - Large AO - Dual coupling2026-01-08 Straight Acetabular Reamer Handle- for hip arthroplasty
07630055307262 - Cup Reamer Size 422025-12-29 Acetabular Reamer
07630055307279 - Cup Reamer Size 442025-12-29 Acetabular Reamer
07630055307286 - Cup Reamer Size 462025-12-29 Acetabular Reamer
07630055307293 - Cup Reamer Size 482025-12-29 Acetabular Reamer
07630055307309 - Cup Reamer Size 502025-12-29 Acetabular Reamer
07630055307316 - Cup Reamer Size 522025-12-29 Acetabular Reamer

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