ACE Acetabular Reamer 59mm 00-501-410-59

GUDID 07630055305480

Acetabular Reamer

Incipio Devices SA

Acetabular orthopaedic reamer
Primary Device ID07630055305480
NIH Device Record Key3f45c42f-7218-42ce-a856-558080010c49
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Acetabular Reamer 59mm
Version Model Number50141059
Catalog Number00-501-410-59
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 Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter
Outer Diameter59 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055305480 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

Moist Heat or Steam Sterilization


[07630055305480]

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

07630055303790 - Offset reamer handle - Hudson - Dual Coupling2025-12-23 30° Offset Reamer Handle for hip arthroplasty
07630055303820 - Offset reamer handle - large AO - Dual Coupling2025-12-23 30° Offset Reamer Handle for hip arthroplasty
07630055303875 - Offset reamer handle - Stryker Z/H - Dual Coupling2025-12-23 30° Offset Reamer Handle for hip arthroplasty
07630055307217 - 55° Angled reamer handle - Stryker Z/H - Dual coupling2025-12-22 55° Angled Reamer Handle for hip arthroplasty
07630055307224 - Offset reamer handle - Stryker Z/H - Dual Coupling2025-12-22 30° Offset Reamer Handle for hip arthroplasty
07630055307231 - Offset reamer handle - Handle2025-12-22 Handle accessory for Offset Reamer Handle
07630055307248 - Straight reamer handle - Stryker Z/H - Dual coupling2025-12-22 Straight Acetabular Reamer Handle- for hip arthroplasty
07630055307255 - Straight reamer handle - Stryker Z/H - Dual coupling (NL)2025-12-22 Straight Acetabular Reamer Handle- for hip arthroplasty

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