ALL TERRAIN - Kids Advanced Bandages, assorted sizes, 5- 1 1/8 - ROSEMONT VENTURES, INC.

Duns Number:933509465

Device Description: Kids Advanced Bandages, assorted sizes, 5- 1 1/8 in x 2 5/8 in (28 mm x 67 mm), 10- 7/8 in

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More Product Details

Catalog Number

-

Brand Name

ALL TERRAIN

Version/Model Number

608503050012

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"

Yes

For Single-Use

Yes

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

e07f120e-1e5b-4e70-8d0f-d3f0ab93ad91

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

10608503050019

Quantity per Package

72

Contains DI Package

00608503050012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ROSEMONT VENTURES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2