Catalog Number

-

Brand Name

UNITY 9100

Version/Model Number

UVP-9100

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

K181292

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Public Device Record Key

6383cd4b-c08a-4451-ae28-c9885204dba4

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

December 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-