Catalog Number

-

Brand Name

Topical Skin Adhesive

Version/Model Number

LXS6M

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

-

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

K151182,K151182

Product Code

MPN

Product Code Name

Tissue adhesive for the topical approximation of skin

Public Device Record Key

cd670d68-fb77-44dc-bb51-df7a1cf6bdd3

Public Version Date

June 24, 2022

Public Version Number

2

DI Record Publish Date

November 26, 2020

Package DI Number

20884521806198

Quantity per Package

6

Contains DI Package

10884521806191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK