Rx Knee All Poly Tibia Augment - Full - 4mm

GUDID 09348215111335

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized
Primary Device ID09348215111335
NIH Device Record Key8e800ef6-b832-4ecd-9f64-75e830d0a456
Commercial Distribution StatusIn Commercial Distribution
Brand NameRx Knee All Poly Tibia Augment - Full - 4mm
Version Model Number121-20-9247
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
GS109348215111335 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

On-Brand Devices [Rx Knee All Poly Tibia Augment - Full - 4mm]

09348215111359121-20-9249
09348215111342121-20-9248
09348215111335121-20-9247
09348215111328121-20-9246
09348215111311121-20-9245
09348215111304121-20-9244
09348215111298121-20-9243
09348215111281121-20-9242
09348215111274121-20-9241
09348215110321121-20-9169
09348215110314121-20-9168
09348215110307121-20-9167
09348215110291121-20-9166
09348215110284121-20-9165
09348215110277121-20-9164
09348215110260121-20-9163
09348215110253121-20-9162
09348215110246121-20-9161

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