Welly - Waterproof Flexible Foam Tape - WELLY HEALTH PBC

Duns Number:116766884

Device Description: Waterproof Flexible Foam Tape

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More Product Details

Catalog Number

-

Brand Name

Welly

Version/Model Number

WLY1012

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)

-

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

da81b37b-b34f-4094-a36f-8e95af55b792

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLY HEALTH PBC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33