AccessGUDID - DEVICE: EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm (07898959543340)

GUDID

Device Identifier (DI) Information

Brand Name: EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm
Version or Model: DM0011FAA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DM0011FAA
Company Name: Micromar Indústria e Comércio Ltda

Primary DI Number: 07898959543340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 902807742 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141455	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 11mm OD, 7mm ID, 3mm Shelf

Device Record Status

Public Device Record Key: 56843538-410d-4cb5-bc9f-bde64c31ad96
Public Version Date: August 01, 2019
Public Version Number: 1
DI Record Publish Date: July 24, 2019