Catalog Number

MSC091050

Brand Name

Medline

Version/Model Number

MSC091050

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"

Yes

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

K183570,K183570,K183570

Product Code

MPN

Product Code Name

Tissue adhesive for the topical approximation of skin

Public Device Record Key

f4995fe9-fc3e-4fe9-8ba9-ad0924e25f02

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

20888277728605

Quantity per Package

6

Contains DI Package

10888277728608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX