Integra® Miltex® - Carbide Burs, RA, 1/2 - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: Carbide Burs, RA, 1/2

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More Product Details

Catalog Number

DRA1/2

Brand Name

Integra® Miltex®

Version/Model Number

DRA1/2

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

EJL

Product Code Name

BUR, DENTAL

Device Record Status

Public Device Record Key

5c465151-7400-443d-b5c2-a32041be4938

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

October 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3