Dense bone drill PROGRESSIVE-LINE - Dense bone drill PROGRESSIVE-LINE, d 3.3 mm - ALTATEC GmbH

Duns Number:322018193

Device Description: Dense bone drill PROGRESSIVE-LINE, d 3.3 mm

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More Product Details

Catalog Number

J5072.3300

Brand Name

Dense bone drill PROGRESSIVE-LINE

Version/Model Number

J5072.3300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EJL

Product Code Name

Bur, Dental

Device Record Status

Public Device Record Key

792e70c7-6987-4ecb-be7e-eb6cc8884500

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALTATEC GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 290
2 A medical device with a moderate to high risk that requires special controls. 901