MediMax Tech

GUDID 20817325023058

Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster

MEDIMAX TECH INC.

Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system
Primary Device ID20817325023058
NIH Device Record Key8051d0db-dff8-4fc1-aa5b-836897493b9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMediMax Tech
Version Model NumberEcoEvRNH-10
Company DUNS927071162
Company NameMEDIMAX TECH INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8556334629
Emailsupport@medimaxtech.com
Phone8556334629
Emailsupport@medimaxtech.com
Phone8556334629
Emailsupport@medimaxtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817325023054 [Primary]
GS110817325023051 [Package]
Contains: 00817325023054
Package: Inner Pack [10 Units]
In Commercial Distribution
GS120817325023058 [Package]
Contains: 10817325023051
Package: Master Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-31

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