Catalog Number

-

Brand Name

DIEGO OTOLOGY TUBE SET FOR USE WITH VIPER HANDPIECES 40" (101.6 cm)L

Version/Model Number

70338007

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

K020594,K020594

Product Code

ERL

Product Code Name

DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Public Device Record Key

e09781c8-9cd8-46cb-a418-8ca824ab5d3a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

00821925026247

Quantity per Package

6

Contains DI Package

00821925034457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-