Distal Cut Adaptor

GUDID 09348215031633

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant/instrument adaptor, reusable
Primary Device ID09348215031633
NIH Device Record Key3a6cb7b6-97e8-4cf4-8d83-2bfae49d85ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Cut Adaptor
Version Model Number122-16-0245
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
GS109348215031633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

Moist Heat or Steam Sterilization


[09348215031633]

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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