Catalog Number

SBL8-GI

Brand Name

TopClosure

Version/Model Number

3S Hospital Pack 8mm

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MKY

Product Code Name

System, Skin Closure

Public Device Record Key

35e3b78c-ae01-4b12-af98-77da0a46eac7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 13, 2017

Package DI Number

27290111502204

Quantity per Package

10

Contains DI Package

17290111502207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Distribution Carton