MediMax Tech - SPDEI-5 - EvaQMaxPen, Smoke Pencil, Double - MEDIMAX TECH INC.

Duns Number:927071162

Device Description: SPDEI-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, SPDEI-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, 5 Meter hose - Each

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More Product Details

Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

SPDEI-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092732,K143103,K092732,K143103,K092732,K143103,K092732,K143103

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

7f564242-1781-44a4-a77e-a06e04fbdc06

Public Version Date

August 11, 2020

Public Version Number

2

DI Record Publish Date

April 04, 2019

Additional Identifiers

Package DI Number

20817325023485

Quantity per Package

40

Contains DI Package

10817325023488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"MEDIMAX TECH INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 309