U-Motion II PS Cup, Ø46mm, ID32mm 1306-3047

GUDID 04711605580649

U-Motion II PS Cup, Ø46mm, ID32mm

UNITED ORTHOPEDIC CORP.

Ceramic-on-polyethylene total hip prosthesis
Primary Device ID04711605580649
NIH Device Record Keyb0664452-3e4b-4689-8c63-65ff1beca16d
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-Motion II PS Cup, Ø46mm, ID32mm
Version Model Number1306-3047
Catalog Number1306-3047
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

Outer Diameter46 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104711605580649 [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 Number3
Public Version Date2018-08-06
Device Publish Date2018-04-19

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