Origin Broach

GUDID 09348215039745

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215039745
NIH Device Record Keya0d9ce99-a0e8-4e53-bb91-7e738cff7708
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrigin Broach
Version Model Number111-18-1309
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 Datefalse
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
GS109348215039745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215039745]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-04
Device Publish Date2018-10-02

On-Brand Devices [Origin Broach]

09348215039783111-18-1809
09348215039776111-18-1609
09348215039769111-18-1509
09348215039752111-18-1409
09348215039745111-18-1309
09348215039738111-18-1209
09348215039721111-18-1109
09348215039714111-18-1009
09348215039707111-18-0909
09348215039691111-18-0809
09348215039684111-18-0609

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