World Rotator Setter

GUDID 09348215046392

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID09348215046392
NIH Device Record Keyecef1482-0e82-48b6-abf3-eb27d1e3d0cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Rotator Setter
Version Model Number122-16-0339
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
GS109348215046392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


[09348215046392]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-18
Device Publish Date2019-02-18

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