Catalog Number

AFFS-G

Brand Name

Grip VersaTek

Version/Model Number

Grip VersaTek Add-on

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JFC

Product Code Name

System, Pressure Measurement, Intermittent

Public Device Record Key

89a8ce71-ad51-40e3-832c-0d38051c2068

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-