SignaSure Cementless Cup

GUDID 09348215031107

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell
Primary Device ID09348215031107
NIH Device Record Keydbb7cd0a-585a-4b70-be24-57ad5d4ddf4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaSure Cementless Cup
Version Model Number111-27-0162
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
GS109348215031107 [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 Cementless Cup]

09348215031114111-27-0164
09348215031107111-27-0162
09348215031091111-27-0160
09348215031084111-27-0158
09348215031077111-27-0156
09348215031060111-27-0154
09348215031053111-27-0152
09348215031046111-27-0150
09348215031039111-27-0148
09348215031022111-27-0146
09348215031015111-27-0144
09348215031008111-27-0142

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