Catalog Number

SS6

Brand Name

SwiftSet

Version/Model Number

SS6

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

K122446,K122446,K122446

Product Code

MPN

Product Code Name

Tissue adhesive for the topical approximation of skin

Public Device Record Key

89c44d4e-6763-4913-97ee-04298b007e6f

Public Version Date

November 23, 2018

Public Version Number

4

DI Record Publish Date

January 07, 2017

Package DI Number

30884521196777

Quantity per Package

36

Contains DI Package

10884521196773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE