Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: 00842331118586
• Version / Model: 5560-11
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-19
• Public Version: 1
• Public Version Date: 2019-01-21
• Public Version Status: New
• Public Device Record Key: 57813d5d-9d03-41c6-99f6-71688887fbde

Device Description

cooley anastomosis clamp, jaws calibrated at 5.0 mm intervals, 6 1/2" (16.5 cm), 7.0 mm jaw depth

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46374	Vascular Doppler clamp	An instrument with an integrated ultrasound transducer used for the detection and temporary occlusion of blood vessels during a surgical procedure. It is typically a held-hand device that is placed on the vasculature to be affected. It is connected to an appropriate signal receiver, and using the Doppler effect (variation in the frequency of a wave of energy (as measured by an observer) due to relative motion between the observer and the source of the wave), will provide the user with information regarding achieved occlusion of the vessel(s). It is typically used on uterine arteries during laparoscopic myomectomy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331118586	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	16.5	Centimeter