TenSURE

Basic Information

• Brand Name: TenSURE
• Primary DI: 00818354017618
• Version / Model: 7 lb
• Catalog Number: 8002
• Company Name: ATRICURE, INC.
• Labeler DUNS: 006133784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-19
• Public Version: 2
• Public Version Date: 2020-04-16
• Public Version Status: Update
• Public Device Record Key: 970645b8-ecf5-42bf-94ef-3eb232d5ceb4

Device Description

A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. 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: 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
47462	Suture knot-tying device	A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818354017618	GS1
Previous	M95580020	HIBCC

Customer Contacts

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