Bur PM2-125 80K diamond extra coarse Ø6.0mm sterile - Bien-Air Surgery SA

Duns Number:481597719

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More Product Details

Catalog Number

1100491-001

Brand Name

Bur PM2-125 80K diamond extra coarse Ø6.0mm sterile

Version/Model Number

1100491

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

8818a241-0493-4495-b7d5-3a8c23a02f85

Public Version Date

February 07, 2019

Public Version Number

1

DI Record Publish Date

January 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIEN-AIR SURGERY SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 69