Remedy Hip Stem

GUDID 09348215053093

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular
Primary Device ID09348215053093
NIH Device Record Key8b629fb2-f4e2-4cfc-b44b-d911b02eda61
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemedy Hip Stem
Version Model NumberD111-19-0100
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
GS109348215053093 [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 Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [Remedy Hip Stem]

09348215053338D111-19-1201
09348215053321D111-19-1101
09348215053314D111-19-1001
09348215053307D111-19-0901
09348215053291D111-19-0801
09348215053284D111-19-0701
09348215053277D111-19-0601
09348215053260D111-19-0501
09348215053253D111-19-0401
09348215053246D111-19-0301
09348215053239D111-19-0201
09348215053222D111-19-0101
09348215053215D111-19-0001
09348215053208D111-19-1200
09348215053192D111-19-1100
09348215053185D111-19-1000
09348215053178D111-19-0900
09348215053161D111-19-0800
09348215053154D111-19-0700
09348215053147D111-19-0600
09348215053130D111-19-0500
09348215053123D111-19-0400
09348215053116D111-19-0300
09348215053109D111-19-0200
09348215053093D111-19-0100
09348215053086D111-19-0000

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