ESOP HA SIZER Ø11

GUDID 03661489560415

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID03661489560415
NIH Device Record Key9035f6b8-e0fd-4748-86b9-0287e3557035
Commercial Distribution StatusIn Commercial Distribution
Brand NameESOP HA SIZER Ø11
Version Model Number256041
Company DUNS261839898
Company NameFOURNITURES HOSPITALIERES INDUSTRIE
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661489560415 [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 Usetrue
Device Is Sterilefalse

[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


[03661489560415]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2019-03-13

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