Grass - Genuine GRASS 10mm Gold Cup-Disc - NATUS MANUFACTURING LIMITED

Duns Number:896421240

Device Description: Genuine GRASS 10mm Gold Cup-Disc Electrode-Reusable

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More Product Details

Catalog Number

-

Brand Name

Grass

Version/Model Number

FH-E5GH-72

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

-

Prescription Use (Rx)

-

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

5dd822f5-1843-4118-a8e2-8299b06b7de5

Public Version Date

September 15, 2020

Public Version Number

3

DI Record Publish Date

August 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS MANUFACTURING LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 154