LC Instrument Tray

GUDID 09348215039448

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray
Primary Device ID09348215039448
NIH Device Record Keyad0e32be-90dc-4805-ab54-7cff09366a2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLC Instrument Tray
Version Model Number112-152-122
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
GS109348215039448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


[09348215039448]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-18
Device Publish Date2019-05-27

On-Brand Devices [LC Instrument Tray]

09348215039448112-152-122
09348215076443112-152-321
09348215076436112-152-320
09348215098773112-152-823

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