Everglade Stem, Standard Offset

GUDID 09348215107116

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215107116
NIH Device Record Key0da1c89c-7e7c-4ace-8ebd-3c9c436ce132
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Stem, Standard Offset
Version Model Number111-45-0611
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
GS109348215107116 [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, Standard Offset]

09348215107178111-45-1211
09348215107161111-45-1111
09348215107154111-45-1011
09348215107147111-45-0911
09348215107130111-45-0811
09348215107123111-45-0711
09348215107116111-45-0611
09348215107109111-45-0511
09348215107093111-45-0411
09348215107086111-45-0311
09348215107079111-45-0211
09348215107062111-45-0111
09348215107055111-45-0011

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