Catalog Number

900008001

Brand Name

Zip 8i Surgical Skin Closure Device

Version/Model Number

900008001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2019

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

3d70f6bc-1052-4e1e-a31a-5c6440138cea

Public Version Date

February 01, 2021

Public Version Number

4

DI Record Publish Date

August 02, 2018

Package DI Number

10853114007086

Quantity per Package

10

Contains DI Package

00853114007089

Package Discontinue Date

March 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Zip 8i, 10-pack