U2 Hip Stem, Revision Hip Stem With Collar, Straig 1104-1214

GUDID 04712602340397

Revision hip stem, Ti plasma spray, With collar, Straight, Ø14x180mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340397
NIH Device Record Keye78a381b-8dd1-4736-bb61-3bd6e2dd3fb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Hip Stem, Revision Hip Stem With Collar, Straig
Version Model Number1104-1214
Catalog Number1104-1214
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
GS104712602340397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, 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 [U2 Hip Stem, Revision Hip Stem With Collar, Straig]

04712602340427Revision hip stem, Ti plasma spray, With collar, Straight, Ø18x180mm
04712602340410Revision hip stem, Ti plasma spray, With collar, Straight, Ø16.5x180mm
04712602340403Revision hip stem, Ti plasma spray, With collar, Straight, Ø15x180mm
04712602340397Revision hip stem, Ti plasma spray, With collar, Straight, Ø14x180mm
04712602340380Revision hip stem, Ti plasma spray, With collar, Straight, Ø13x180mm
04712602340373Revision hip stem, Ti plasma spray, With collar, Straight, Ø12x180mm
04712602340366Revision hip stem, Ti plasma spray, With collar, Straight, Ø11x180mm

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