SignaSure Trial Poly

GUDID 09348215080044

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable
Primary Device ID09348215080044
NIH Device Record Key047f2a1d-c964-43c4-82b4-33a065281b0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaSure Trial Poly
Version Model Number112-35-0254
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
GS109348215080044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

Moist Heat or Steam Sterilization

[09348215080044]

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 Poly]

09348215080099112-35-0264
09348215080082112-35-0262
09348215080075112-35-0260
09348215080068112-35-0258
09348215080051112-35-0256
09348215080044112-35-0254
09348215080037112-35-0252
09348215080013112-35-0250
09348215079994112-35-0248
09348215079987112-35-0247
09348215079970112-35-0245
09348215079949112-35-0242
09348215083519112-35-0243
09348215079918112-35-0267
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