Everglade Broach

GUDID 09348215105136

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215105136
NIH Device Record Keyc2c21108-415a-4ec3-9960-0ab3006800c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Broach
Version Model Number111-45-2003
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
GS109348215105136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

Moist Heat or Steam Sterilization


[09348215105136]

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 Broach]

09348215105228111-45-2012
09348215105211111-45-2011
09348215105204111-45-2010
09348215105198111-45-2009
09348215105181111-45-2008
09348215105174111-45-2007
09348215105167111-45-2006
09348215105150111-45-2005
09348215105143111-45-2004
09348215105136111-45-2003
09348215105129111-45-2002
09348215105112111-45-2001
09348215105105111-45-2000

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