Signature Femoral Head

GUDID 09348215001773

SIGNATURE ORTHOPAEDICS PTY LTD

Metallic femoral head prosthesis
Primary Device ID09348215001773
NIH Device Record Keyefb5c4e5-fe88-4d6d-962c-406f2551d595
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignature Femoral Head
Version Model Number111-152-042
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
GS109348215001773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-09-28

On-Brand Devices [Signature Femoral Head]

09348215017903111-152-003
09348215017897111-152-002
09348215017880111-152-001
09348215001797111-152-044
09348215001780111-152-043
09348215001773111-152-042
09348215001766111-152-041
09348215001759111-152-034
09348215001742111-152-033
09348215001735111-152-032
09348215001728111-152-031
09348215001711111-152-024
09348215001704111-152-023
09348215001698111-152-022
09348215001681111-152-021
09348215001674111-152-013
09348215001667111-152-012
09348215001650111-152-011
09348215002039111-152-644
09348215002022111-152-643
09348215002015111-152-642
09348215002008111-152-641
09348215001995111-152-634
09348215001988111-152-633
09348215001971111-152-632
09348215001964111-152-631
09348215001957111-152-624
09348215001940111-152-623
09348215001933111-152-622
09348215001926111-152-621
09348215001919111-152-613
09348215001902111-152-612
09348215001896111-152-611
09348215001889111-152-533
09348215001872111-152-532
09348215001865111-152-531
09348215001858111-152-523
09348215001841111-152-522
09348215001834111-152-521
09348215001827111-152-513
09348215001810111-152-512
09348215001803111-152-511
0934821509561101-045-00-4008
0934821509560401-045-00-4004
0934821509559801-045-00-4000
0934821509558101-045-00-4094
0934821509557401-045-00-3608
0934821509556701-045-00-3604
0934821509555001-045-00-3600
0934821509554301-045-00-3694

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