Tibial Tray

GUDID 09348215041533

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray
Primary Device ID09348215041533
NIH Device Record Keya682dadd-73a8-405a-8867-1d8c3d160563
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Tray
Version Model Number122-10-0160
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215041533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215041533]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-13
Device Publish Date2019-05-27

On-Brand Devices [Tibial Tray]

09348215041540122-10-0161
09348215041533122-10-0160
09348215041526122-10-0159
09348215041519122-10-0158
09348215041502122-10-0157
09348215041496122-10-0156
09348215041489122-10-0155

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