Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M1206

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)

-

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

808cb47a-5184-446f-8d74-005dc4498dc6

Public Version Date

July 17, 2020

Public Version Number

1

DI Record Publish Date

July 09, 2020

Package DI Number

10813799005128

Quantity per Package

6

Contains DI Package

00813799005114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box