EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm

Basic Information

• Brand Name: EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm
• Primary DI: 07898959543333
• Version / Model: DM0010FAA
• Catalog Number: DM0010FAA
• Company Name: Micromar Indústria e Comércio Ltda
• Labeler DUNS: 902807742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-24
• Public Version: 1
• Public Version Date: 2019-08-01
• Public Version Status: New
• Public Device Record Key: eb4e8da9-e798-4607-bed6-9820d0c7836e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Neurology	882.4305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46277	Automatic cranial perforator, single-use	A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898959543333	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141455	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14mm OD, 11mm ID, 3mm Shelf

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry