Modular Trial Cage 16mm

GUDID 09348215067649

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215067649
NIH Device Record Keyc0ade068-f200-4cab-9b14-f165aceb2ded
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Trial Cage 16mm
Version Model Number132-072-316
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
GS109348215067649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


[09348215067649]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

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