World Knee Vit-E UC Poly Insert

GUDID 09348215092030

SIGNATURE ORTHOPAEDICS PTY LTD

Tibial insert
Primary Device ID09348215092030
NIH Device Record Keyd8a5e8bd-f8f7-4a8b-a5c3-ad2d868dd9d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E UC Poly Insert
Version Model Number121-20-7262
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215092030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [World Knee Vit-E UC Poly Insert]

09348215092726121-20-7968
09348215092719121-20-7967
09348215092702121-20-7966
09348215092696121-20-7965
09348215092689121-20-7964
09348215092672121-20-7963
09348215092665121-20-7962
09348215092658121-20-7961
09348215092641121-20-7960
09348215092634121-20-7868
09348215092627121-20-7867
09348215092610121-20-7866
09348215092603121-20-7865
09348215092597121-20-7864
09348215092580121-20-7863
09348215092573121-20-7862
09348215092566121-20-7861
09348215092559121-20-7860
09348215092542121-20-7768
09348215092535121-20-7767
09348215092528121-20-7766
09348215092511121-20-7765
09348215092504121-20-7764
09348215092498121-20-7763
09348215092481121-20-7762
09348215092474121-20-7761
09348215092467121-20-7760
09348215092450121-20-7668
09348215092443121-20-7667
09348215092436121-20-7666
09348215092429121-20-7665
09348215092412121-20-7664
09348215092405121-20-7663
09348215092399121-20-7662
09348215092382121-20-7661
09348215092375121-20-7660
09348215092368121-20-7568
09348215092351121-20-7567
09348215092344121-20-7566
09348215092337121-20-7565
09348215092320121-20-7564
09348215092313121-20-7563
09348215092306121-20-7562
09348215092290121-20-7561
09348215092283121-20-7560
09348215092276121-20-7468
09348215092269121-20-7467
09348215092252121-20-7466
09348215092245121-20-7465
09348215092238121-20-7464

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