Catalog Number

PS3002

Brand Name

Zip PreLoc 2 Wound Closure Device

Version/Model Number

PS3002

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

MKY

Product Code Name

System, Skin Closure

Public Device Record Key

168172b8-1d3c-410d-906d-07c72d341d6c

Public Version Date

June 25, 2021

Public Version Number

6

DI Record Publish Date

May 21, 2020

Package DI Number

10853114007277

Quantity per Package

5

Contains DI Package

00853114007270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack