Scanlan® SURG-I-LOOP® silicone loops

Basic Information

• Brand Name: Scanlan® SURG-I-LOOP® silicone loops
• Primary DI: 00846159027730
• Version / Model: 1001-77B
• Catalog Number: 1001-77B
• Company Name: SCANLAN INTERNATIONAL INC
• Labeler DUNS: 023055619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-12
• Public Version: 2
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 30397a20-4359-4197-979c-213d8750a434

Device Description

Scanlan® SURG-I-LOOP® silicone loops - Blue Mini, 1.5x.88 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg)

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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAE	Snare, Surgical	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
Primary	00846159027730	GS1

Customer Contacts

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