SureCUT

Basic Information

• Brand Name: SureCUT
• Primary DI: 10840143901799
• Version / Model: 50-01
• Catalog Number: FG-0006
• Company Name: ATRICURE, INC.
• Labeler DUNS: 006133784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-11
• Public Version: 1
• Public Version Date: 2021-01-19
• Public Version Status: New
• Public Device Record Key: 420dd398-83e6-4efd-973a-b476cbde129d

Device Description

SureCUT Suture Cutter

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FZT	Cutter, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64565	Pericardioscopic access cannula	A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest and through the pericardial cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive cardiac procedure (e.g., epicardial ablation). It is intended for subxiphoid or transdiaphragmatic access, and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade intended to assist introduction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840143901786	GS1	box	1	In Commercial Distribution
Primary	10840143901799	GS1
Previous	00818354017595	GS1
Package	50840143901766	GS1	case	10	In Commercial Distribution