ACE Acetabular Reamer 48mm 00-501-410-48

GUDID 07630055305374

Acetabular Reamer

Incipio Devices SA

Acetabular orthopaedic reamer
Primary Device ID07630055305374
NIH Device Record Keyc7300380-7d25-4fe7-a076-4b65f33db069
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Acetabular Reamer 48mm
Version Model Number50141048
Catalog Number00-501-410-48
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 Dimensions

Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter
Outer Diameter48 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055305374 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


[07630055305374]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-08
Device Publish Date2025-04-30

Devices Manufactured by Incipio Devices SA

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07630055303714 - 55° Angled reamer handle - Hudson - Tri coupling (NC)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
07630055303721 - 55° Angled reamer handle - Hudson - Tri coupling (NL)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
07630055303745 - 55° Angled reamer handle - large AO - Tri coupling (NC)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
07630055303752 - 55° Angled reamer handle - large AO - Tri coupling (NL)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
07630055303776 - 55° Angled reamer handle - Stryker Z/H - Tri coupling (NC)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery
07630055303783 - 55° Angled reamer handle - Stryker Z/H - Tri coupling (NL)2025-12-08 55° Angled Reamer Handle for hip arthroplasty surgery

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