Encore Stem Trial Neck

GUDID 09348215083175

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215083175
NIH Device Record Key900bbf5e-89f5-4514-9722-b26b778a4ab2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncore Stem Trial Neck
Version Model Number111-45-0016
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
GS109348215083175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


[09348215083175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-14
Device Publish Date2021-10-06

On-Brand Devices [Encore Stem Trial Neck]

09348215083243111-45-1017
09348215083236111-45-0717
09348215083229111-45-0617
09348215083212111-45-1016
09348215083205111-45-0716
09348215083199111-45-0416
09348215083182111-45-0216
09348215083175111-45-0016
09348215083168111-45-1015
09348215083151111-45-0715
09348215083144111-45-0415
09348215083137111-45-0215
09348215083120111-45-0015

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