FDA.reportPublic FDA data

Obturator 20mm

Primary DI
ENOU5153NOU9
Brand
Obturator 20mm
Company
Nouvag AG
Model
5153NOU
Device description
Obturator 20mm
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
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ENOU5153NOU9PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece setA collection of sterile devices that are components of a tissue morcellation system used to mechanically cut (slice), core (cut a hole into), peel (remove surface) and extract selected tissue from the body during surgery. It typically consists primarily of a tissue morcellation system handpiece (high-speed rotating blade and holder), a handpiece obturator, and a disposable remote drive cable. This is a single-use 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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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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

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