Catalog Number

370866

Brand Name

RUGBY

Version/Model Number

370866

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

0cdd3b5e-1369-4b45-80d9-b396d6e205d4

Public Version Date

August 07, 2020

Public Version Number

3

DI Record Publish Date

June 10, 2020

Package DI Number

50880681034007

Quantity per Package

24

Contains DI Package

00880681034002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE