V2 TRIVERSE I-BEAM OSTEOTOME

GUDID 09348215127640

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic osteotome blade, reusable
Primary Device ID09348215127640
NIH Device Record Key4e3a52e0-9867-41b9-bcc1-dbcf8d21cba5
Commercial Distribution StatusIn Commercial Distribution
Brand NameV2 TRIVERSE I-BEAM OSTEOTOME
Version Model Number122-22-0056
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
GS109348215127640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWMOsteotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


[09348215127640]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-17
Device Publish Date2025-04-09

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09348215125004 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X6.22025-04-17
09348215125011 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 31X82025-04-17
09348215125028 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 34X8.52025-04-17
09348215125035 - V2 TRIVERSE ASYMM PATELLA TRIAL SZ 37X102025-04-17
09348215125417 - V2 TRIVERSE LOCKING BAR PI2025-04-17
09348215125431 - V2 TRIVERSE FEMORAL NOTCH REAMER2025-04-17

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