Dermapro - PE Waterproof Adhesive tape 2 inch x 5 yards - SAFE N' SIMPLE LLC

Duns Number:807812412

Device Description: PE Waterproof Adhesive tape 2 inch x 5 yards

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More Product Details

Catalog Number

SNS57220

Brand Name

Dermapro

Version/Model Number

SNS57220

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

0b5ed700-4067-461b-808e-0d13873eba71

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

August 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFE N' SIMPLE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
U Unclassified 15