Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: 00842331103100
• Version / Model: 5640-19T
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-04
• Public Version: 2
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: d6d5b05f-f5ef-42b6-aa21-97718a601ae1

Device Description

CV Elite - Titanium Debakey Micro Clamp, debakey jaws, 9.0 mm jaws, 20.0 mm jaw length, slightly angled shanks, 4-3/8" (11.2 cm)

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
63552	Surgical A/V-shaped microvessel clamp	A hand-held surgical instrument designed to compress the severed end of a small vessel (e.g., blood vessel, vas deferens) to occlude the vessel, typically prior to anastomosis formation. Often referred to as an Acland clamp, it has an A-/V-shaped design whereby the vessel is slid into the mouth of the clamp up to the apex where it is compressed; it does not have a hinge/jaws (i.e., it is not forceps or a bulldog clamp). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331103100	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	11.2	Centimeter