Ceramic Femoral Head BIOLOX® Delta 12/14L 1203-5440

GUDID 04712771495331

Ceramic Femoral Head, Delta, O.D.φ40mm, 12/14- L

UNITED ORTHOPEDIC CORP.

Ceramic-on-ceramic total hip prosthesis
Primary Device ID04712771495331
NIH Device Record Keyfae59f65-ee44-44db-85c1-3283fc7a4c34
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic Femoral Head BIOLOX® Delta 12/14L
Version Model Number1203-5440
Catalog Number1203-5440
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 Diameter40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712771495331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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 12/14L]

04712771495331Ceramic Femoral Head, Delta, O.D.φ40mm, 12/14- L
04712771495294Ceramic Femoral Head, Delta, O.D.φ36mm, 12/14- L
04712771494952Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- L
04712771494945Ceramic Femoral Head, Delta, O.D.φ28mm, 12/14- L

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