Everglade Stem, 127 Neck

GUDID 09348215107390

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215107390
NIH Device Record Key7c205401-8ef6-4874-8ca6-e82afb28add3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverglade Stem, 127 Neck
Version Model Number111-45-0114
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
GS109348215107390 [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, 127 Neck]

09348215107451111-45-0614
09348215107444111-45-0514
09348215107420111-45-0414
09348215107413111-45-0314
09348215107406111-45-0214
09348215107390111-45-0114
09348215107383111-45-0014

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