U1 Total Hip System 1401-2044

GUDID 04719872168171

Acetabular cup liner trial 44mm

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial
Primary Device ID04719872168171
NIH Device Record Key2472b86a-c612-460c-909c-c54cd29f2393
Commercial Distribution StatusIn Commercial Distribution
Brand NameU1 Total Hip System
Version Model Number1401-2044
Catalog Number1401-2044
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exempttrue
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
GS104719872168171 [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 Usetrue
Device Is Sterilefalse

[04719872168171]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-07
Device Publish Date2017-05-16

On-Brand Devices [U1 Total Hip System]

04719872168171Acetabular cup liner trial 44mm
04711605584388Femoral sizer, anterior reference
04711605584166Bipolar cap gauge
04711605583527Femoral A/P chamfer cutting guide, #4.5
04711605583510Femoral A/P chamfer cutting guide, #3.5
04711605583503Femoral A/P chamfer cutting guide, #2.5
04711605583497Femoral A/P chamfer cutting guide, #1.5
04719872168331U2 Acetabular cup liner trial, ID28mm, 10°×56mm
04719872168324U2 Acetabular cup liner trial, ID28mm, 10°×54mm
04719872168317U2 Acetabular cup liner trial, ID28mm, 10°×52mm
04719872168300U2 Acetabular cup liner trial, ID28mm, 10°×50mm
04719872168294U2 Acetabular cup liner trial, ID28mm, 10°×48mm
04719872168287U2 Acetabular cup liner trial, ID26mm, 10°×46mm
04719872168270U2 Acetabular cup liner trial, ID26mm, 10°×44mm
04719872168362U2 Acetabular cup liner trial, ID28mm, 10°×62mm
04719872168355U2 Acetabular cup liner trial, ID28mm, 10°×60mm
04719872168348U2 Acetabular cup liner trial, ID28mm, 10°×58mm

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