Origin DAA Stem, High Offset

GUDID 09348215088446

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular
Primary Device ID09348215088446
NIH Device Record Keycf4a24af-2f7e-4348-99c5-ce4dc2d10f9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrigin DAA Stem, High Offset
Version Model Number111-39-1113
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
GS109348215088446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

On-Brand Devices [Origin DAA Stem, High Offset]

09348215088569111-39-1813
09348215088545111-39-1613
09348215088521111-39-1513
09348215088507111-39-1413
09348215088484111-39-1313
09348215088460111-39-1213
09348215088446111-39-1113
09348215088422111-39-1013
09348215088408111-39-0913
09348215088385111-39-0813
09348215036454111-39-1803
09348215036447111-39-1603
09348215036430111-39-1503
09348215036423111-39-1403
09348215036416111-39-1303
09348215036409111-39-1203
09348215036393111-39-1103
09348215036386111-39-1003
09348215036379111-39-0903
09348215036362111-39-0803

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.