Trial Head Ø22mm -3.5mm

GUDID 09348215072605

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215072605
NIH Device Record Key1ddf3787-b88c-40a5-9b12-570a9f228d14
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Head Ø22mm -3.5mm
Version Model Number112-35-0003
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
GS109348215072605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215072605]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

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