Soft Flex-S - Soft Flex Electrodes - Short - ZETO INC

Duns Number:079582566

Device Description: Soft Flex Electrodes - Short

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ZP-200-51011

Brand Name

Soft Flex-S

Version/Model Number

ZP-200-51011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

4eed825a-4670-4170-aaa9-8e15e1991590

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZETO INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5