Catalog Number

CAT01358

Brand Name

NanoPass

Version/Model Number

CAT01358

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 04, 2015

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

-

Product Code

HWQ

Product Code Name

PASSER

Public Device Record Key

3c9aa5bc-ec02-4a7c-a2c8-9a408e1a6f8c

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

September 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-