TSI Stem Broach

GUDID 09348215040529

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach
Primary Device ID09348215040529
NIH Device Record Keyfcd9fbdd-6afb-4325-95d5-687ea6a4e506
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI Stem Broach
Version Model Number112-28-0044
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
GS109348215040529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215040529]

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 [TSI Stem Broach]

09348215040529112-28-0044
09348215040512112-28-0043
09348215040505112-28-0008
09348215040499111-23-2050
09348215040482111-23-2040
09348215040475111-23-2030
09348215040468111-23-2020
09348215040451111-23-2010
09348215040444111-23-2000

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