UKNEE Total Knee System 9301-5105

GUDID 04711605582674

Slide hammer assembly

UNITED ORTHOPEDIC CORP.

Surgical mallet
Primary Device ID04711605582674
NIH Device Record Key4aee2c7c-4aa0-4aa5-8003-a3c9ece1363d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUKNEE Total Knee System
Version Model Number9301-5105
Catalog Number9301-5105
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
GS104711605582674 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04711605582674]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-17
Device Publish Date2017-06-28

On-Brand Devices [UKNEE Total Knee System]

04719872179375Head pin, 20mm
04711605582858Femoral IM alignment guide
04711605582728Femoral distal cutting guide
04711605582674Slide hammer assembly
04719886909197Gap gauge , 13mm

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