Ceramic Liner Impact Adaptor

GUDID 09348215039387

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant impactor, reusable
Primary Device ID09348215039387
NIH Device Record Key50a51246-def9-45e8-8da7-a4e36597ec3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic Liner Impact Adaptor
Version Model Number112-152-305
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
GS109348215039387 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

Moist Heat or Steam Sterilization


[09348215039387]

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

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215039295 - Liner Impactor2026-02-09
09348215039301 - Liner Impactor2026-02-09
09348215039318 - Liner Impactor2026-02-09
09348215039325 - Liner Impactor2026-02-09
09348215039332 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039349 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039356 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039363 - Ceramic Liner Inserter Impactor Head2026-02-09

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