Catalog Number

-

Brand Name

Skin Affix

Version/Model Number

M1204

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

K132243,K132243,K132243

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

857dfa92-6eb4-497c-acd0-f88e6621e0fd

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

00897392000240

Quantity per Package

6

Contains DI Package

00897392000233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton