U2 U-Motion Acetabular Component 1203-2232-RA

GUDID 04719872167839

Ceramic femoral head trial, φ32mm, M

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial
Primary Device ID04719872167839
NIH Device Record Keyd9973d59-d3b8-41f7-941c-f17e2d48f435
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 U-Motion Acetabular Component
Version Model Number1203-2232-RA
Catalog Number1203-2232-RA
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
GS104719872167839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719872167839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-06-25

On-Brand Devices [U2 U-Motion Acetabular Component]

04719872167860Ceramic femoral head trial, φ32mm, L
04719872167853Ceramic femoral head trial, φ28mm, L
04719872167839Ceramic femoral head trial, φ32mm, M
04719872167822Ceramic femoral head trial, φ28mm, M
04719872167808Ceramic femoral head trial, φ32mm, S
04719872167792Ceramic femoral head trial, φ28mm, S

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