Catalog Number

EX70407

Brand Name

exofin HVTA ST&G, 1g Box of 10

Version/Model Number

EX70407

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152476,K152476

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

b08ce508-2802-4d6b-8937-0162ec0982bc

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

30854137001147

Quantity per Package

60

Contains DI Package

20854137001140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case