EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm - Micromar Indústria e Comércio Ltda

Duns Number:902807742

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More Product Details

Catalog Number

DM0010FAA

Brand Name

EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm

Version/Model Number

DM0010FAA

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

K141455

Product Code Details

Product Code

HBF

Product Code Name

Drills, Burrs, Trephines & Accessories (Compound, Powered)

Device Record Status

Public Device Record Key

eb4e8da9-e798-4607-bed6-9820d0c7836e

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROMAR INDÚSTRIA E COMÉRCIO LTDA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16