Nuwave - NUWAVE with Large Bag - EXCELERON MEDICAL, INC.

Duns Number:825179992

Device Description: NUWAVE with Large Bag

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More Product Details

Catalog Number

NW-003

Brand Name

Nuwave

Version/Model Number

NW-003

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRJ

Product Code Name

Disinfectant, Medical Devices

Device Record Status

Public Device Record Key

b2b17421-1c68-47bd-9bfe-f3d5df563653

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXCELERON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 1