NA

Basic Information

• Brand Name: NA
• Primary DI: 10849771050770
• Version / Model: Vascular Loops
• Catalog Number: VL202
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-03-22
• Public Version: 2
• Public Version Date: 2025-03-17
• Public Version Status: Update
• Public Device Record Key: 66950dee-0d6a-4b7d-8549-363117393a48
• Distribution End Date: 2025-03-14

Device Description

Vascular Loops, Sterile, Blue, Mini, 18-inch long, 2 per package

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: Yes
• 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
KDC	INSTRUMENT, SURGICAL, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61916	Surgical vessel loop	A nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50849771050778	GS1	Box	10	Not in Commercial Distribution	2025-03-14
Primary	10849771050770	GS1
Unit of Use	00849771050773	GS1
Previous	00849771030843	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K896676	000