SureCUT

Basic Information

• Brand Name: SureCUT
• Primary DI: 10840143909610
• Version / Model: 50-01
• Catalog Number: FG-0006-02
• Company Name: ATRICURE, INC.
• Labeler DUNS: 006133784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 1
• Public Version Date: 2023-04-14
• Public Version Status: New
• Public Device Record Key: 4ad5eec3-3971-485a-9b38-3661fd829d22

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: MR Safe
• 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
63487	Suture cutter, single-use	A hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840143909614	GS1	box	1	In Commercial Distribution
Primary	10840143909610	GS1
Package	50840143909618	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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