Ceramic Femoral Head BIOLOX® Delta 12/14M 1203-5232

GUDID 04712771494938

Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- M

UNITED ORTHOPEDIC CORP.

Ceramic-on-polyethylene total hip prosthesis
Primary Device ID04712771494938
NIH Device Record Keyde159ccb-cee9-4851-bed1-631d9ece7f37
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic Femoral Head BIOLOX® Delta 12/14M
Version Model Number1203-5232
Catalog Number1203-5232
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
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+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Outer Diameter32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712771494938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-03
Device Publish Date2015-10-24

On-Brand Devices [Ceramic Femoral Head BIOLOX® Delta 12/14M]

04712771495324Ceramic Femoral Head, Delta, O.D.φ40mm, 12/14- M
04712771495287Ceramic Femoral Head, Delta, O.D.φ36mm, 12/14- M
04712771494938Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- M
04712771494921Ceramic Femoral Head, Delta, O.D.φ28mm, 12/14- M

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