U2 Hip Stem, Ti Porous Coated 1104-3045

GUDID 04712602340816

UNITED U2 Hip stem, Ti porous coated, #4, Ø12

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340816
NIH Device Record Key69b3d604-103c-4314-a23e-4fb7accfa30a
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Hip Stem, Ti Porous Coated
Version Model Number1104-3045
Catalog Number1104-3045
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

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602340816 [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

On-Brand Devices [U2 Hip Stem, Ti Porous Coated]

04712602340847UNITED U2 Hip stem, Ti porous coated, #7, Ø15
04712602340830UNITED U2 Hip stem, Ti porous coated, #6, Ø14
04712602340823UNITED U2 Hip stem, Ti porous coated, #5, Ø13
04712602340816UNITED U2 Hip stem, Ti porous coated, #4, Ø12
04712602340809UNITED U2 Hip stem, Ti porous coated, #3, Ø11
04712602340793UNITED U2 Hip stem, Ti porous coated, #2, Ø10
04712602340786UNITED U2 Hip stem, Ti porous coated, #1, Ø9

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