Patella Drill Guide

GUDID 09348215117757

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09348215117757
NIH Device Record Keya7d7cdc7-c575-438c-98d3-58cef52b5e6d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Drill Guide
Version Model Number122-18-1602
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS109348215117757 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


[09348215117757]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-03
Device Publish Date2025-08-26

On-Brand Devices [Patella Drill Guide]

09348215074166122-15-0448
09348215041861122-10-0254
09348215041854122-10-0253
09348215041847122-10-0252
09348215041830122-10-0251
09348215117757122-18-1602

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