ACE Acetabular Reamer 68mm 00-501-410-68

GUDID 07630055305572

Acetabular Reamer

Incipio Devices SA

Acetabular orthopaedic reamer
Primary Device ID07630055305572
NIH Device Record Key14c15f8a-a3a6-43e2-9da3-5409bb4cd2c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE Acetabular Reamer 68mm
Version Model Number50141068
Catalog Number00-501-410-68
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 Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630055305572 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

Moist Heat or Steam Sterilization


[07630055305572]

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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07630055305305 - ACE Acetabular Reamer 41mm2025-05-08 Acetabular Reamer
07630055305312 - ACE Acetabular Reamer 42mm2025-05-08 Acetabular Reamer
07630055305329 - ACE Acetabular Reamer 43mm2025-05-08 Acetabular Reamer

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