Catalog Number

7614

Brand Name

Zip 8i Surgical Skin Closure Device

Version/Model Number

667614001

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

06d18d16-4ca1-4334-bbe6-ad61abc13716

Public Version Date

February 01, 2021

Public Version Number

5

DI Record Publish Date

March 16, 2017

Package DI Number

10853114007017

Quantity per Package

10

Contains DI Package

00853114007010

Package Discontinue Date

March 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Zip®8i, 10-pack, BSC