ACE Acetabular Reamer 47mm 00-501-410-47

GUDID 07630055305367

Acetabular Reamer

Incipio Devices SA

Acetabular orthopaedic reamer
Primary Device ID07630055305367
NIH Device Record Key55fb465e-8626-4a9a-9bd9-12428b2116ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Acetabular Reamer 47mm
Version Model Number50141047
Catalog Number00-501-410-47
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 Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter
Outer Diameter47 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055305367 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

Moist Heat or Steam Sterilization


[07630055305367]

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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07630055300102 - Offset Cup Impactor - M8x1.25 Interface2026-02-09 Offset Cup Impactor - M8x1.25 Interface
07630055301369 - Offset Cup Impactor - M8x0.75 interface2026-02-09 Offset Cup Impactor for hip arthroplasty
07630055306296 - Straight reamer handle - large AO - Dual coupling (NL)2026-02-06 Straight Acetabular Reamer Handle- for hip arthroplasty
07630055306302 - Straight reamer handle - Stryker Z/H - Dual coupling (NL)2026-02-06 Straight Acetabular Reamer Handle- for hip arthroplasty
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

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