FDA.report

Cutting tube 15mm

Primary DI
ENOU5155NOU9
Brand
Cutting tube 15mm
Company
Nouvag AG
Model
5155NOU
Device description
Cutting tube 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ENOU5155NOU9PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+41718466600info@nouvag.com

Regulatory Flags

DUNS number
480610476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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ENOU4163US0Dispenser DP 30 LipoPlus4163US2017-01-13
ENOU4180US0Dispenser DP 304180US2017-01-13
ENOU4181US0Dispenser DP 30 LipoPlus4181US2017-01-13
ENOU4186US0Dispenser DP 304186US2018-08-21
ENOU4187US0Dispenser DP 304187US2017-01-13
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ENOU4245USA9Suction jar 4L4245usa2021-12-14
ENOU1043NOU0Surgical handpiece 4:11043nou2021-06-11
ENOU1706A0Tubing set1706a2021-04-19
ENOU1706B0Tubing set1706b2021-04-19
H7871140900111000Dispenser DP 304187-115ang2017-01-13
H7871140900123000Dispenser DP 304187-230ang2017-01-13
ENOU4180230ANG0Dispenser DP 304180-230ang2021-01-12
ENOU33620LipoSurg33622018-08-21
ENOU33920LipoSurg33922018-08-21
ENOU41139Sterilisation container for Mesher41132018-08-21
ENOU41269Silicone mat for sterilisation container for Mesher41262018-08-21
ENOU41279Filter pack for sterilisation container for Mesher41272018-08-21
ENOU1737NOU9Support sleeve with distal protector1737NOU2019-08-21

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