DragonFly™ BUR, DMD, RD, 100MM L, 1.4MM Ø, RW - DragonFly™ Round Diamond Bur 100MM LENGTH, 1.4MM - Grace Medical, Inc.

Duns Number:030849173

Device Description: DragonFly™ Round Diamond Bur 100MM LENGTH, 1.4MM Ø, ROUND WINDOW Rx ONLY - USED WITH 950-0 DragonFly™ Round Diamond Bur 100MM LENGTH, 1.4MM Ø, ROUND WINDOW Rx ONLY - USED WITH 950-002 HANDPIECE

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More Product Details

Catalog Number

-

Brand Name

DragonFly™ BUR, DMD, RD, 100MM L, 1.4MM Ø, RW

Version/Model Number

951-100-014-RW

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

8a2db2f6-2322-4fc7-8544-aabfcb7ae62d

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

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