U2 Femoral component, PS 2103-3270

GUDID 04712771505559

U2 Femoral component, PS, #7, right

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis
Primary Device ID04712771505559
NIH Device Record Key8162f9bc-305d-4982-850d-18b8e37b3078
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2 Femoral component, PS
Version Model Number2103-3270
Catalog Number2103-3270
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
GS104712771505559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-13
Device Publish Date2015-10-24

On-Brand Devices [U2 Femoral component, PS]

04712771505559U2 Femoral component, PS, #7, right
04712771505542U2 Femoral component, PS, #7, left
04712602345712U2 Femoral component, PS, #6, right
04712602345705U2 Femoral component, PS, #5, right
04712602345699U2 Femoral component, PS, #4, right
04712602345682U2 Femoral component, PS, #3, right
04712602345675U2 Femoral component, PS, #2, right
04712602345668U2 Femoral component, PS, #1, right
04712602345651U2 Femoral component, PS, #6, left
04712602345644U2 Femoral component, PS, #5, left
04712602345637U2 Femoral component, PS, #5, left
04712602345620U2 Femoral component, PS, #3, left
04712602345613U2 Femoral component, PS, #2, left
04712602345606U2 Femoral component, PS, #1, left

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