U1 Hip System, Acetabular Cup Liner 1401-1062

GUDID 04712602343084

U1 Acetabular cup liner assembly, 20°hooded,62mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602343084
NIH Device Record Key4b118ae7-1d8a-49e0-8574-39337fef8d32
Commercial Distribution StatusIn Commercial Distribution
Brand NameU1 Hip System, Acetabular Cup Liner
Version Model Number1401-1062
Catalog Number1401-1062
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 Diameter62 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602343084 [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 Date2018-08-02
Device Publish Date2015-10-24

On-Brand Devices [U1 Hip System, Acetabular Cup Liner]

04712602343084U1 Acetabular cup liner assembly, 20°hooded,62mm
04712602343077U1 Acetabular cup liner assembly, 20°hooded,60mm
04712602343060U1 Acetabular cup liner assembly, 20°hooded,58mm
04712602343053U1 Acetabular cup liner assembly, 20°hooded,56mm
04712602343046U1 Acetabular cup liner assembly, 20°hooded,54mm
04712602343039U1 Acetabular cup liner assembly, 20°hooded,52mm
04712602343022U1 Acetabular cup liner assembly, 20°hooded,50mm
04712602343015U1 Acetabular cup liner assembly, 20°hooded,48mm
04712602343008U1 Acetabular cup liner assembly, 20°hooded,46mm
04712602342995U1 Acetabular cup liner assembly, 20°hooded,44mm

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