Trial Cage 25deg 22L

GUDID 09348215066833

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215066833
NIH Device Record Keye6fc841c-f64e-4e15-8863-6058e4aee1e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Cage 25deg 22L
Version Model Number132-15-0153
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
GS109348215066833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


[09348215066833]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-08
Device Publish Date2020-06-30

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09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
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