Electronic motor 21 - Electronic motor 21 80'000 RPM - Nouvag AG

Duns Number:480610476

Device Description: Electronic motor 21 80'000 RPM

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More Product Details

Catalog Number

-

Brand Name

Electronic motor 21

Version/Model Number

2098NOU

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

ERL

Product Code Name

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Device Record Status

Public Device Record Key

ffcd7498-cf32-4194-a656-7cddedfd8848

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOUVAG AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 95