Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

1565C-4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

58a138d6-2b65-48bd-a048-288c495fc9a1

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 06, 2019

Package DI Number

M3681565C32

Quantity per Package

12

Contains DI Package

M3681565C31

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box