Everglade Trial Neck, Ultra High Offset

GUDID 09348215105297

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215105297
NIH Device Record Keye6968779-493d-47ce-94ef-32b651127d65
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Trial Neck, Ultra High Offset
Version Model Number111-45-2026
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
GS109348215105297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

Moist Heat or Steam Sterilization


[09348215105297]

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

On-Brand Devices [Everglade Trial Neck, Ultra High Offset]

09348215105297111-45-2026
09348215105266111-45-2023

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.