Universal guide handle assembly

GUDID 03661489556982

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID03661489556982
NIH Device Record Keyc23ba525-9cc7-485f-8d28-985fabf66245
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal guide handle assembly
Version Model Number255698
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
GS103661489556982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

Moist Heat or Steam Sterilization


[03661489556982]

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

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