Sterion® Vessel Loop

Basic Information

• Brand Name: Sterion® Vessel Loop
• Primary DI: 00840113228584
• Version / Model: 016001BBG
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-25
• Public Version: 1
• Public Version Date: 2021-03-05
• Public Version Status: New
• Public Device Record Key: 3cd75a76-c9db-406b-801d-f76013814729

Device Description

Intended to be used to occlude, retract and identify arteries, veins, tendons and nerves in surgical procedures

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDC	INSTRUMENT, SURGICAL, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36082	Medical/surgical string	A sterile slender cord or thick thread, medical grade, designed to temporarily lift vessels, hold tracheostomy tubes in place, or assist in stabilizing various organs, medical instrumentation and accessories. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840113228591	GS1		100	In Commercial Distribution
Primary	00840113228584	GS1

Customer Contacts

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