FDA.reportPublic FDA data

Universal Chuck Set for the IntelliSense Drill System

Primary DI
B666MCG80070
Brand
Universal Chuck Set for the IntelliSense Drill System
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
1.0
Catalog number
MCG8007
Device description
Universal Key to the keyed chuck for IntelliSense Drill
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B666MCG80070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill chuck keyA hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. It is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3073156403support@mcginleyinnovations.com

Regulatory Flags#

DUNS number
078568266
Device count
1
Premarket exempt
true
Serial number
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

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