SignaSure Trial Shell

GUDID 09348215084554

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215084554
NIH Device Record Key45fb7d5e-d74d-4771-a447-917f1cb80ea7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaSure Trial Shell
Version Model Number112-35-0460
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
GS109348215084554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

Moist Heat or Steam Sterilization


[09348215084554]

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 Trial Shell]

09348215084578112-35-0464
09348215084561112-35-0462
09348215084554112-35-0460
09348215084547112-35-0458
09348215084530112-35-0456
09348215084523112-35-0454
09348215084516112-35-0452
09348215084509112-35-0450
09348215084493112-35-0448
09348215084486112-35-0446
09348215084479112-35-0444
09348215084462112-35-0442

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