Skintact - Neutral Electrode - Leonhard Lang GmbH

Duns Number:302846407

Device Description: Neutral Electrode

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More Product Details

Catalog Number

RS25A30

Brand Name

Skintact

Version/Model Number

RS25A30

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

f74c5189-4e37-463d-9157-4f5c0e23ec73

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

June 01, 2016

Additional Identifiers

Package DI Number

29005531593248

Quantity per Package

50

Contains DI Package

19005531593241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LEONHARD LANG GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9
3 A medical device with high risk that requires premarket approval 17