Catalog Number

2560J

Brand Name

ZIP Pen

Version/Model Number

2560J

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"

-

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,K141587

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

a9a1cca9-a11a-4c89-83b4-ae5486be981b

Public Version Date

June 11, 2021

Public Version Number

7

DI Record Publish Date

September 04, 2018

Package DI Number

50614559105755

Quantity per Package

80

Contains DI Package

10614559105757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE