U2 Hip Stem, HA/Ti Plasma Spray 1104-1012

GUDID 04712602340236

UNITED U2 Hip stem, HA/Ti plasma spray, #1, Ø9

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340236
NIH Device Record Key1ffb6b61-415b-4f72-a65a-8e6217f0ace1
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Hip Stem, HA/Ti Plasma Spray
Version Model Number1104-1012
Catalog Number1104-1012
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
GS104712602340236 [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 Date2018-08-02
Device Publish Date2015-10-24

On-Brand Devices [U2 Hip Stem, HA/Ti Plasma Spray]

04712602340359UNITED U2 Hip stem, HA/Ti plasma spray, #7, Ø15
04712602340342UNITED U2 Hip stem, HA/Ti plasma spray, #6, Ø14
04712602340335UNITED U2 Hip stem, HA/Ti plasma spray, #6, Ø13
04712602340328UNITED U2 Hip stem, HA/Ti plasma spray, #5, Ø13
04712602340311UNITED U2 Hip stem, HA/Ti plasma spray, #5, Ø12
04712602340304UNITED U2 Hip stem, HA/Ti plasma spray, #4, Ø12
04712602340298UNITED U2 Hip stem, HA/Ti plasma spray, #4, Ø11
04712602340281UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø12
04712602340274UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø11
04712602340267UNITED U2 Hip stem, HA/Ti plasma spray, #3, Ø10
04712602340250UNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø11
04712602340243UNITED U2 Hip stem, HA/Ti plasma spray, #2, Ø10
04712602340236UNITED U2 Hip stem, HA/Ti plasma spray, #1, Ø9

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