FDA.reportPublic FDA data

Motor

Primary DI
00846338002688
Brand
Motor
Company
ELLIQUENCE, LLC
Model
16-0105
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338002688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338002688008463380026888463380026880846338002688

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motor, electricA hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
019872358
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338001209IEC BiPolar Cable, DisposableIEC-DJX/12026-06-03
00846338001230Bipolar CableBCD-EU/12026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsBCD-FP/12026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsIEC-JX/B2026-06-03
00846338001582IEC Power Cord 110vIEC-PC1102026-06-03
00846338001605IEC Power Cord 220v ANZ PlugIEC-PCANZ2026-06-03
00846338001612IEC Power Cord 220v EuropeIEC-PCEU2026-06-03
00846338001629IEC Power Cord U.K. 220vIEC-PCUK2026-06-03
00846338005436Working Port15-29062026-06-02
00846338005689Curette15-25372026-06-02
00846338005696Curette15-25382026-06-02
00846338005702Curette15-25392026-06-02
00846338005719Forceps15-16312026-06-02
00846338005726Forceps15-16322026-06-02
00846338005757Forceps15-16432026-06-02
00846338005764Forceps15-16442026-06-02
00846338005771Forceps15-16512026-06-02
00846338005788Forceps15-16522026-06-02
00846338005801Kerrison15-19252026-06-02
00846338005818Kerrison15-19262026-06-02

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