Catalog Number

M1201

Brand Name

Octylbond

Version/Model Number

M1201

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

-

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

3c236c4b-3a37-41f0-bd66-1d12925de7a2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 18, 2016

Package DI Number

20854137001195

Quantity per Package

6

Contains DI Package

10854137001198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6