U2 Acetabular Cup, Ti Plasma Spray, Multi-hole 1303-3680

GUDID 04712771482553

U2 Acetabular cup, Ti plasma spray, multi-hole, Ø80mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712771482553
NIH Device Record Key6c7adb37-a30e-43b0-bad4-e0ce2214c8e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Acetabular Cup, Ti Plasma Spray, Multi-hole
Version Model Number1303-3680
Catalog Number1303-3680
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 Diameter80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712771482553 [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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04712771482409U2 Acetabular cup, Ti plasma spray, multi-hole, Ø50mm
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