Encore Stem Broach

GUDID 09348215064594

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215064594
NIH Device Record Keyb1f9b9e7-e06c-490a-a11b-5a777f8eed00
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncore Stem Broach
Version Model Number111-45-0714
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
GS109348215064594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

Moist Heat or Steam Sterilization


[09348215064594]

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 Broach]

09348215064648111-45-1214
09348215064631111-45-1114
09348215064624111-45-1014
09348215064617111-45-0914
09348215064600111-45-0814
09348215064594111-45-0714
09348215064587111-45-0614
09348215064570111-45-0514
09348215064563111-45-0414
09348215064556111-45-0314
09348215064549111-45-0214
09348215064532111-45-0114
09348215064525111-45-0014

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