Cemented Origin Stem

GUDID 09348215054724

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated femoral stem prosthesis, one-piece
Primary Device ID09348215054724
NIH Device Record Key092ebe4c-0cbb-4fa4-81c7-7fd0bc1d0e55
Commercial Distribution StatusIn Commercial Distribution
Brand NameCemented Origin Stem
Version Model Number111-42-1403
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
GS109348215054724 [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 Date2020-08-17
Device Publish Date2020-08-07

On-Brand Devices [Cemented Origin Stem]

09348215054755111-42-1803
09348215054748111-42-1603
09348215054731111-42-1503
09348215054724111-42-1403
09348215054717111-42-1303
09348215054700111-42-1203
09348215054694111-42-1103
09348215054687111-42-1003
09348215054670111-42-0903
09348215054663111-42-0803
09348215054656111-42-1802
09348215054649111-42-1602
09348215054632111-42-1502
09348215054625111-42-1402
09348215054618111-42-1302
09348215054601111-42-1202
09348215054595111-42-1102
09348215054588111-42-1002
09348215054571111-42-0902
09348215054564111-42-0802

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