FDA.reportPublic FDA data

Electronic motor 21

Primary DI
ENOU2098NOU0
Brand
Electronic motor 21
Company
Nouvag AG
Model
2098NOU
Device description
Electronic motor 21 80'000 RPM
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
GEYMotor, Surgical Instrument, Ac-Powered
HBCMotor, Drill, Electric
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1
HBCMotor, Drill, ElectricNeurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENOU2098NOU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered surgical power tool system motorA compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41718466600info@nouvag.com

Regulatory Flags#

DUNS number
480610476
Device count
1
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
ENOU2090NOU0Electronic motor 212090NOU2017-01-13
ENOU32800TCM 3000 BL32802018-08-21
ENOU33350MD 1133352017-01-13
ENOU3335SAL0MD 113335SAL2018-08-31
ENOU33600HighSurg 3033602017-01-13
ENOU42751150Vacuson 404275-1152017-01-13
ENOU42801150Vacuson 604280-1152017-01-13
ENOU5040NOU0Micro compass saw MSS 50005040NOU2018-08-21
ENOU5053NOU0Contra Angle 20:15053nou2017-04-27
ENOU5077NOU0CHP Handpiece5077NOU2018-08-21
ENOU5090NOU0Micro oscillating saw OMS 50005090NOU2018-08-21
ENOU5110NOU0Micro sagittal saw MOS 50005110NOU2018-08-21
ENOU5200NOU0Contra Angle 16:15200nou2017-04-27
ENOU5201NOU0Contra Angle 32:15201nou2017-04-27
ENOU33620LipoSurg33622018-08-21
ENOU42271150Vacuson 404227-1152018-08-21
ENOU4161US0Dispenser DP 30 LipoPlus4161US2017-01-13
ENOU4163US0Dispenser DP 30 LipoPlus4163US2017-01-13
ENOU4180US0Dispenser DP 304180US2017-01-13
ENOU4181US0Dispenser DP 30 LipoPlus4181US2017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22