FDA.reportPublic FDA data

EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm

Primary DI
07898959543074
Brand
EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm
Company
Micromar Indústria e Comércio Ltda
Model
DM0210FAA
Catalog number
DM0210FAA
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141455000EASYDRILL AUTOSTOP CRANIAL PERFORATORMicromar Ind. Com. , Ltd.2015-03-16HBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898959543074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898959543074078989595430747898959543074

GMDN Terms#

Term, Definition table
TermDefinition
Automatic cranial perforator, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep away from sunlight, Keep dry

Contacts#

Phone, Email table
PhoneEmail
1-800-433-7080xx@xx.xx

Regulatory Flags#

DUNS number
902807742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898959543593EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmDM0010FAADM0010FAA2023-10-30
07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmDM0210FAADM0210FAA2023-10-30
07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmDM0011FAADM0011FAA2023-10-30
07898959543623EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmDM0008FAADM0008FAA2023-10-30
07898959543555EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmDM0008FAADM0008FAA2022-12-02
07898959543562EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmDM0011FAADM0011FAA2022-12-02
07898959543579EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmDM0210FAADM0210FAA2022-12-02
07898959543586EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmDM0010FAADM0010FAA2022-12-02
07898959543470EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmDM0010FAADM0010FAA2022-05-23
07898959543487EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmDM0210FAADM0210FAA2022-05-23
07898959543494EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmDM0011FAADM0011FAA2022-05-23
07898959543500EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmDM0008FAADM0008FAA2022-05-23
07898959543166EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmDM0008FAADM0008FAA2020-03-31
07898959543173EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmDM0011FAADM0011FAA2020-03-31
07898959543180EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmDM0210FAADM0210FAA2020-03-31
07898959543197EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmDM0010FAADM0010FAA2020-03-31
07898959543326EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmDM0008FAADM0008FAA2019-07-24
07898959543333EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmDM0010FAADM0010FAA2019-07-24
07898959543340EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmDM0011FAADM0011FAA2019-07-24
07898959543357EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmDM0210FAADM0210FAA2019-07-24

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07898959543593EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
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