DragonFly™ Skinny BUR, 100MM x 1.0MM - DragonFly™ ROUND DIAMOND "Skinny" BUR 100MM - Grace Medical, Inc.

Duns Number:030849173

Device Description: DragonFly™ ROUND DIAMOND "Skinny" BUR 100MM LENGTH, 1.0MM Ø, Rx ONLY-USED WITH 950-002 HAN DragonFly™ ROUND DIAMOND "Skinny" BUR 100MM LENGTH, 1.0MM Ø, Rx ONLY-USED WITH 950-002 HANDPIECE

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More Product Details

Catalog Number

-

Brand Name

DragonFly™ Skinny BUR, 100MM x 1.0MM

Version/Model Number

951-100-010-SB

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

fc545c31-4675-40f4-b2ad-7c7f72a905f5

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRACE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 200
2 A medical device with a moderate to high risk that requires special controls. 564