N/A - BUR 31061064 1MM 64MM L ROUND CARBIDE - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: BUR 31061064 1MM 64MM L ROUND CARBIDE

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

31061064

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

-

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

19ba7817-ba61-4a00-8f95-e9210c4cb2ba

Public Version Date

October 09, 2020

Public Version Number

3

DI Record Publish Date

September 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10