FDA.reportPublic FDA data

TCM 3000 BL

Primary DI
ENOU32800
Brand
TCM 3000 BL
Company
Nouvag AG
Model
3280
Device description
Surgical motor system
Published
2018-08-21
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
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
ENOU32800PrimaryHIBCC0

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
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
ENOU2090NOU0Electronic motor 212090NOU2017-01-13
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
ENOU4186US0Dispenser DP 304186US2018-08-21

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