101401500

GUDID 10603295001232

BANTAM FEMORAL HEAD Diameter 22.225mm +0 10/12 TAPER

DEPUY ORTHOPAEDICS, INC.

Metallic femoral head prosthesis
Primary Device ID10603295001232
NIH Device Record Key1e4b4a90-2a6c-475b-b857-4b04c711364d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1014-01-500
Catalog Number101401500
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295001232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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10603295552666 - SUMMIT2025-05-08 SUMMIT MAKE TO ORDER LATERAL OFFSET ANT APPROACH BROACH HANDLE RIGHT
10603295552765 - SUMMIT2025-05-08 SUMMIT MAKE TO ORDER LATERAL OFFSET ANT APPROACH BROACH HANDLE LEFT

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