SignaSure Cup Backing Plate

GUDID 09348215084783

SIGNATURE ORTHOPAEDICS PTY LTD

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Primary Device ID09348215084783
NIH Device Record Keyfc262467-d5ea-4ab5-a02e-c46d1e922940
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaSure Cup Backing Plate
Version Model Number112-35-0744
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 Datetrue
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
GS109348215084783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


[09348215084783]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-07
Device Publish Date2022-01-28

On-Brand Devices [SignaSure Cup Backing Plate]

09348215084882112-35-0764
09348215084875112-35-0762
09348215084868112-35-0760
09348215084851112-35-0758
09348215084844112-35-0756
09348215084837112-35-0754
09348215084820112-35-0752
09348215084813112-35-0750
09348215084806112-35-0748
09348215084790112-35-0746
09348215084783112-35-0744
09348215084776112-35-0742

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