Catalog Number

-

Brand Name

ZIP Pen

Version/Model Number

2560

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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"

-

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

K141587,K141587

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

05681371-dc15-489b-a07f-5844f58242f0

Public Version Date

December 31, 2021

Public Version Number

6

DI Record Publish Date

December 14, 2016

Package DI Number

30614559104198

Quantity per Package

10

Contains DI Package

10614559104194

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-