Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

UNNA-C3

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

d4b2ca77-d9b4-4d9f-a128-1df876ddf61c

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 06, 2019

Package DI Number

M368UNNAC32

Quantity per Package

12

Contains DI Package

M368UNNAC31

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box