FDA.reportPublic FDA data

Obturator 15mm

Primary DI
ENOU5152NOU9
Brand
Obturator 15mm
Company
Nouvag AG
Model
5152NOU
Device description
Obturator 15mm
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
ENOU5152NOU9PrimaryHIBCC0

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

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
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538950Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29