STANDARD IMPACTOR

GUDID 03661489375774

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 ID03661489375774
NIH Device Record Key2ae32a42-f1b0-4f7e-af59-0652cdb1da9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTANDARD IMPACTOR
Version Model Number237577
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
GS103661489375774 [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

[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

Moist Heat or Steam Sterilization


[03661489375774]

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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03661489481130 - TELEGRAPH®2024-02-19
03661489500114 - TELEGRAPH®2024-02-19
03661489500138 - TELEGRAPH®2024-02-19
03661489500145 - TELEGRAPH®2024-02-19
03661489500169 - TELEGRAPH®2024-02-19

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