U-Motion II Set of Screw Hole Covers 1306-1001

GUDID 04712771497441

U-Motion II Set of Screw Hole Covers

UNITED ORTHOPEDIC CORP.

Ceramic-on-ceramic total hip prosthesis
Primary Device ID04712771497441
NIH Device Record Key07b5d473-a772-47d2-b524-38953334e5e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Motion II Set of Screw Hole Covers
Version Model Number1306-1001
Catalog Number1306-1001
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 Identifiers

Device Issuing AgencyDevice ID
GS104712771497441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-07
Device Publish Date2015-10-24

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