Catalog Number

7778K1

Brand Name

MicroFrance®

Version/Model Number

7778K1

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

-

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

EQJ

Product Code Name

BUR, EAR, NOSE AND THROAT

Public Device Record Key

f2ef3724-a2a9-472f-b078-1a422e0c22c4

Public Version Date

October 03, 2022

Public Version Number

3

DI Record Publish Date

June 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-