Aria Reduced Distal

GUDID 09348215032012

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215032012
NIH Device Record Keya26d1215-5c2a-4ac2-80cb-dc97619c567b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAria Reduced Distal
Version Model Number111-20-6405
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
GS109348215032012 [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 Date2019-09-24
Device Publish Date2019-09-16

On-Brand Devices [Aria Reduced Distal]

09348215055318111-20-6400
09348215055301111-20-6300
09348215055295111-20-6402
09348215055288111-20-6401
09348215055271111-20-6302
09348215055264111-20-6301
09348215032081111-20-6412
09348215032074111-20-6411
09348215032067111-20-6410
09348215032050111-20-6409
09348215032043111-20-6408
09348215032036111-20-6407
09348215032029111-20-6406
09348215032012111-20-6405
09348215032005111-20-6404
09348215031992111-20-6403

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