FDA.reportPublic FDA data

IntelliSense Drill Technology

Primary DI
B666MCG100100
Brand
IntelliSense Drill Technology
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
1.0
Catalog number
MCG100-10S
Device description
IntelliSense Drill Bit 1.0mm x 100mm
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBit, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143191000IntelliSense DrillMcginley Innovations2015-02-20HWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B666MCG100101PackageHIBCC10In Commercial Distribution
B666MCG100100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use"A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a ""twist drill"", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device."

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
307-315-6403support@mcginleyinnovations.com

Regulatory Flags#

DUNS number
078568266
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B666MCGLD2F0Lever Action Plate System0MCG-LD2F2025-09-23
B666MCGRD2F0Lever Action Plate System0MCG-RD2F2025-09-23
B666MCGLA1F0Lever Action Plate System0MCG-LA1F2020-11-16
B666MCGLA2V0Lever Action Plate System0MCG-LA2V2020-11-16
B666MCGLB1F0Lever Action Plate System0MCG-LB1F2020-11-16
B666MCGLB2V0Lever Action Plate System0MCG-LB2V2020-11-16
B666MCGLC1F0Lever Action Plate System0MCG-LC1F2020-11-16
B666MCGLC2V0Lever Action Plate System0MCG-LC2V2020-11-16
B666MCGLD1F0Lever Action Plate System0MCG-LD1F2020-11-16
B666MCGLD2V0Lever Action Plate System0MCG-LD2V2020-11-16
B666MCGLE1F0Lever Action Plate System0MCG-LE1F2020-11-16
B666MCGLE2V0Lever Action Plate System 0MCG-LE2V2020-11-16
B666MCGLF1F0Lever Action Plate System0MCG-LF1F2020-11-16
B666MCGLF2V0Lever Action Plate System0MCG-LF2V2020-11-16
B666MCGRA1F0Lever Action Plate System0MCG-RA1F2020-11-16
B666MCGRA2V0Lever Action Plate System0MCG-RA2V2020-11-16
B666MCGRB1F0Lever Action Plate System0MCG-RB1F2020-11-16
B666MCGRB2V0Lever Action Plate System0MCG-RB2V2020-11-16
B666MCGRC1F0Lever Action Plate System0MCG-RC1F2020-11-16
B666MCGRC2V0Lever Action Plate System0MCG-RC2V2020-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888277374478MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
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