RHINOTEC - 4.0MM RHINOTEC OVAL BUR, OTOLARYNGOLOGY, 6 EA - Conmed Corporation

Duns Number:071595540

Device Description: 4.0MM RHINOTEC OVAL BUR, OTOLARYNGOLOGY, 6 EA

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More Product Details

Catalog Number

N9390

Brand Name

RHINOTEC

Version/Model Number

N9390

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

ed352c53-58d0-4b80-9230-9f867994fb95

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

20845854008383

Quantity per Package

6

Contains DI Package

10845854008386

Package Discontinue Date

-

Package Status

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