Catalog Number

PS2080

Brand Name

Zip 8i Surgical Skin Closure Device

Version/Model Number

PS2080

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)

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

12f74879-0da7-417f-bd24-ecb0c1cef4d3

Public Version Date

May 04, 2021

Public Version Number

5

DI Record Publish Date

August 02, 2018

Package DI Number

10865379000009

Quantity per Package

10

Contains DI Package

00865379000002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack