SignaSure Cemented Cup

GUDID 09348215031169

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell
Primary Device ID09348215031169
NIH Device Record Key60e4950d-4417-4693-9b2e-0bf4e1e0b315
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaSure Cemented Cup
Version Model Number111-27-0650
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215031169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-07
Device Publish Date2022-01-28

On-Brand Devices [SignaSure Cemented Cup]

09348215031237111-27-0664
09348215031220111-27-0662
09348215031213111-27-0660
09348215031206111-27-0658
09348215031190111-27-0656
09348215031183111-27-0654
09348215031176111-27-0652
09348215031169111-27-0650
09348215031152111-27-0648
09348215031145111-27-0646
09348215031138111-27-0644
09348215031121111-27-0642

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