All Poly Monotrial UC

GUDID 09348215081287

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
Primary Device ID09348215081287
NIH Device Record Keyfe4bd571-943a-4bc2-b6b6-609536b94f10
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Poly Monotrial UC
Version Model Number122-18-0471
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
GS109348215081287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


[09348215081287]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-15
Device Publish Date2021-03-05

On-Brand Devices [All Poly Monotrial UC]

09348215081362122-18-0479
09348215081355122-18-0478
09348215081348122-18-0477
09348215081331122-18-0476
09348215081324122-18-0475
09348215081317122-18-0474
09348215081300122-18-0473
09348215081294122-18-0472
09348215081287122-18-0471

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