U2 Acetabular Components, Ti Porous Coated 1303-5456

GUDID 04712602342490

U2 Acetabular cup, Ti porous coated, Ø56mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602342490
NIH Device Record Keyf35512fb-c027-4bc2-b7eb-6d4f796be458
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Acetabular Components, Ti Porous Coated
Version Model Number1303-5456
Catalog Number1303-5456
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 Diameter56 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602342490 [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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04712602342537U2 Acetabular cup, Ti porous coated, Ø64mm
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04712602342513U2 Acetabular cup, Ti porous coated, Ø60mm
04712602342506U2 Acetabular cup, Ti porous coated, Ø58mm
04712602342490U2 Acetabular cup, Ti porous coated, Ø56mm
04712602342483U2 Acetabular cup, Ti porous coated, Ø54mm
04712602342476U2 Acetabular cup, Ti porous coated, Ø52mm
04712602342469U2 Acetabular cup, Ti porous coated, Ø50mm
04712602342452U2 Acetabular cup, Ti porous coated, Ø48mm
04712602342445U2 Acetabular cup, Ti porous coated, Ø46mm
04712602342438U2 Acetabular cup, Ti porous coated, Ø44mm

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