Catalog Number

NK 3116-07

Brand Name

NA

Version/Model Number

NK 3116-07

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

K182785

Product Code

HWN

Product Code Name

Instrument, Compression

Public Device Record Key

ad64e01a-4499-4c92-97ab-6ee66da8bfec

Public Version Date

July 09, 2021

Public Version Number

2

DI Record Publish Date

March 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-