Catalog Number

-

Brand Name

n.a.

Version/Model Number

263070

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

K950964

Product Code

EQJ

Product Code Name

BUR, EAR, NOSE AND THROAT

Public Device Record Key

451aec06-e305-403e-b827-880894ed8c7a

Public Version Date

August 21, 2018

Public Version Number

1

DI Record Publish Date

July 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-