Spartan Stem Broach

GUDID 09348215064471

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach
Primary Device ID09348215064471
NIH Device Record Key8c5997e6-e7c3-433e-9c21-6a5663da4cf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpartan Stem Broach
Version Model Number111-44-2008
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
GS109348215064471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

[09348215064471]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

On-Brand Devices [Spartan Stem Broach]

09348215064518111-44-2012
09348215064501111-44-2011
09348215064495111-44-2010
09348215064488111-44-2009
09348215064471111-44-2008
09348215064464111-44-2007
09348215064457111-44-2006
09348215064440111-44-2005
09348215064433111-44-2004
09348215064426111-44-2003
09348215064419111-44-2002
09348215064402111-44-2001
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