Everglade Trial Neck, 127 Degree

GUDID 09348215108984

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215108984
NIH Device Record Key581f974d-a1a7-4016-80be-d9770fd9f9a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Trial Neck, 127 Degree
Version Model Number111-45-2029
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
GS109348215108984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


[09348215108984]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

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