Bur PM2-70 50K steel Ø4.0mm - Bien-Air Surgery SA

Duns Number:481597719

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

1100299-001

Brand Name

Bur PM2-70 50K steel Ø4.0mm

Version/Model Number

1100299

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

169b1347-b7d0-43ea-a8fa-4e58a0d61110

Public Version Date

June 05, 2020

Public Version Number

1

DI Record Publish Date

May 28, 2020

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