Catalog Number

85200

Brand Name

SureSeal

Version/Model Number

Extra Large

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"

-

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

d094f147-b442-4d21-b13b-b2e3d97f736a

Public Version Date

July 10, 2019

Public Version Number

1

DI Record Publish Date

July 02, 2019

Package DI Number

00894743001048

Quantity per Package

20

Contains DI Package

00894743001024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case