Morcellator

Basic Information

• Brand Name: Morcellator
• Primary DI: ENOU5163NOU0
• Version / Model: 5163NOU
• Company Name: Nouvag AG
• Labeler DUNS: 480610476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cb25163e-1932-46ba-9b20-7a0406e31682

Device Description

Gear unit Morcellator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46736	Tissue morcellation system handpiece set	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ENOU5163NOU0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]