Ceramic Liner Inserter Impactor Head

GUDID 09348215039349

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant impactor, reusable
Primary Device ID09348215039349
NIH Device Record Keyb6bd9f42-ae83-4770-a2d7-4f1c9023c0b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic Liner Inserter Impactor Head
Version Model Number112-152-211
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
GS109348215039349 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


[09348215039349]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-02-09
Device Publish Date2018-10-09

On-Brand Devices [Ceramic Liner Inserter Impactor Head]

09348215039363112-152-213
09348215039356112-152-212
09348215039349112-152-211
09348215039332112-152-210

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