INTEGRAL PROCESS - Open-surgery electrosurgical electrode, - Modern Medical Equipment MFG. Ltd.

Duns Number:527812392

Device Description: Open-surgery electrosurgical electrode, monopolar, single-use

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More Product Details

Catalog Number

-

Brand Name

INTEGRAL PROCESS

Version/Model Number

ES871-MN271-050

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

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

7ba74300-fd62-4c0a-9c2c-c33c1fb7d8bf

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

December 12, 2017

Additional Identifiers

Package DI Number

26939029815778

Quantity per Package

40

Contains DI Package

16939029815771

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box

"MODERN MEDICAL EQUIPMENT MFG. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 165