Cadwell - Disp. EEG Cup+ el. Ag/AgCl 10mm cup 48" wire 10pc - Technomed Engineering B.V.

Duns Number:418415568

Device Description: Disp. EEG Cup+ el. Ag/AgCl 10mm cup 48" wire 10pc

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More Product Details

Catalog Number

-

Brand Name

Cadwell

Version/Model Number

302643-000-048

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

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

41ede56e-3a5b-4ec2-9525-b539e4b80397

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECHNOMED ENGINEERING B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 429