U2 Acetabular Components, Ti Plasma Spray 1303-5668

GUDID 04712602342728

U2 Acetabular cup, Ti plasma spray, Ø68mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602342728
NIH Device Record Key22da282b-9328-4a17-89c2-18f81df1744d
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Acetabular Components, Ti Plasma Spray
Version Model Number1303-5668
Catalog Number1303-5668
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 Diameter68 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602342728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, 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

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