SofTIP

Basic Information

• Brand Name: SofTIP
• Primary DI: 00818354017601
• Version / Model: Long
• Catalog Number: 6002
• Company Name: ATRICURE, INC.
• Labeler DUNS: 006133784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-30
• Public Version: 3
• Public Version Date: 2020-04-16
• Public Version Status: Update
• Public Device Record Key: 50dd7af9-3477-49f2-aa45-a99b9081792d

Device Description

A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.

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: 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
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

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
Primary	00818354017601	GS1
Previous	M95560020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090385	000