Catalog Number

-

Brand Name

InHealth Technologies; Katz

Version/Model Number

FB 5000

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

-

Product Code

KBE

Product Code Name

Snare, Nasal

Public Device Record Key

c0855182-bff4-4b0c-a78b-556d7164702e

Public Version Date

May 08, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2017

Package DI Number

00813307013594

Quantity per Package

5

Contains DI Package

00848253002637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-