Novy

Basic Information

• Brand Name: Novy
• Primary DI: 00827002175587
• Version / Model: G17558
• Catalog Number: J-NCS-504070
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 5caf5c39-1859-482c-b2e2-a5aba69daf38

Device Description

Modified Novy Cornual Cannulation Set

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOV	Catheters, salpingography	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37552	Fallopian tube catheterization kit	A collection of sterile devices designed for the transuterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency during salpingoscopy/fluoroscopy, ultrasonography, hysteroscopy, or laparoscopy. It typically consists of a dedicated catheter with a balloon, a syringe to inflate the balloon, a secondary catheter [e.g., a tungsten (W) tipped catheter], a guidewire, and connectors. Some types may also facilitate the entry of other devices/instruments for procedures within the fallopian tubes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002175587	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.