RHINOTEC - 4.2MM RHINOTEC GATOR, IRRIGATED, 6 EA - Conmed Corporation

Duns Number:071595540

Device Description: 4.2MM RHINOTEC GATOR, IRRIGATED, 6 EA

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More Product Details

Catalog Number

N9220

Brand Name

RHINOTEC

Version/Model Number

N9220

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 2022

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EQJ

Product Code Name

BUR, EAR, NOSE AND THROAT

Device Record Status

Public Device Record Key

10ff18a6-435d-4f9e-a2c2-40a70e335820

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

20845854011956

Quantity per Package

6

Contains DI Package

10845854011959

Package Discontinue Date

June 06, 2022

Package Status

Not in Commercial Distribution

Package Type

CARTON

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95