Catalog Number

SS-050S

Brand Name

SurgiSeal

Version/Model Number

SS-050S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K130474,K130474

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

c79c5ac3-65ce-47c0-867d-f9c13788e4b5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-