Catalog Number

DM0011FAA

Brand Name

EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm

Version/Model Number

DM0011FAA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HBF

Product Code Name

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

Public Device Record Key

a75ddea2-d82b-4440-a73a-18ce8748147b

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-