Everglade Stem, High Offset

GUDID 09348215107246

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215107246
NIH Device Record Keyf73fa192-f1ec-4475-a7c2-356ba690f082
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Stem, High Offset
Version Model Number111-45-0612
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
GS109348215107246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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 [Everglade Stem, High Offset]

09348215107307111-45-1212
09348215107291111-45-1112
09348215107284111-45-1012
09348215107277111-45-0912
09348215107260111-45-0812
09348215107253111-45-0712
09348215107246111-45-0612
09348215107239111-45-0512
09348215107222111-45-0412
09348215107215111-45-0312
09348215107208111-45-0212
09348215107192111-45-0112
09348215107185111-45-0012

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