Wing Handle for Reamer

GUDID 04250337114024

Handles are non-invasive surgical instruments, used as handles in combination with invasive surgical instruments to operate (e.g. move, turn or direct) these instruments in order to exert their function at the area of interest during surgery and therefore qualify as medical devices. Handles are reusable medical devices made of materials appropriate for processing like medical grade silicone or medical-grade stainless steel.

Joimax GmbH

Surgical instrument handle, non-torque-limiting
Primary Device ID04250337114024
NIH Device Record Key30142c3f-f571-4dc0-83bf-a1e98b3232ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameWing Handle for Reamer
Version Model NumberRHD101236
Company DUNS344267187
Company NameJoimax GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104250337114024 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


[04250337114024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-25
Device Publish Date2025-03-17

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