U2 Hip Stem, Revision Hip Stem Collarless, Straigh 1104-1611

GUDID 04712602340571

Revision hip stem, Ti plasma spray, Collarless, Straight, Ø11x180mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340571
NIH Device Record Keydb12fadc-39f2-44ad-827f-30306ce0c251
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Hip Stem, Revision Hip Stem Collarless, Straigh
Version Model Number1104-1611
Catalog Number1104-1611
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
GS104712602340571 [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 Collarless, Straigh]

04712602340632Revision hip stem, Ti plasma spray, Collarless, Straight, Ø18x180mm
04712602340625Revision hip stem, Ti plasma spray, Collarless, Straight, Ø16.5x180mm
04712602340618Revision hip stem, Ti plasma spray, Collarless, Straight, Ø15x180mm
04712602340601Revision hip stem, Ti plasma spray, Collarless, Straight, Ø14x180mm
04712602340595Revision hip stem, Ti plasma spray, Collarless, Straight, Ø13x180mm
04712602340588Revision hip stem, Ti plasma spray, Collarless, Straight, Ø12x180mm
04712602340571Revision hip stem, Ti plasma spray, Collarless, Straight, Ø11x180mm

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