Catalog Number

-

Brand Name

Tissue Seal

Version/Model Number

1051260-P

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

K140343,K140343

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

ae27e61c-c7f6-4530-82d0-ffb4c209a147

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Package DI Number

10860000589038

Quantity per Package

10

Contains DI Package

00860000589031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box