Origin DAA Stem, Standard Offset

GUDID 09348215032531

SIGNATURE ORTHOPAEDICS PTY LTD

Coated femoral stem prosthesis, modular
Primary Device ID09348215032531
NIH Device Record Key620fa089-b88f-4008-8b25-7d785839242f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrigin DAA Stem, Standard Offset
Version Model Number111-39-1402
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
GS109348215032531 [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, Standard Offset]

09348215088552111-39-1812
09348215088538111-39-1612
09348215088514111-39-1512
09348215088491111-39-1412
09348215088477111-39-1312
09348215088453111-39-1212
09348215088439111-39-1112
09348215088415111-39-1012
09348215088392111-39-0912
09348215088378111-39-0812
09348215032562111-39-1802
09348215032555111-39-1602
09348215032548111-39-1502
09348215032531111-39-1402
09348215032524111-39-1302
09348215032517111-39-1202
09348215032500111-39-1102
09348215032494111-39-1002
09348215032487111-39-0902
09348215032470111-39-0802

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