NEUWAVE - Footswitch Locking USB - NEUWAVE MEDICAL, INC.

Duns Number:809758878

Device Description: Footswitch Locking USB

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More Product Details

Catalog Number

FSWITCH2

Brand Name

NEUWAVE

Version/Model Number

FSWITCH2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

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

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Device Record Status

Public Device Record Key

7d643b5a-8064-43e5-8cc1-27cc07e378bb

Public Version Date

October 15, 2021

Public Version Number

3

DI Record Publish Date

November 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUWAVE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 36