Loop

Basic Information

• Brand Name: Loop
• Primary DI: 04953170044953
• Version / Model: MAJ-254
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2022-08-11
• Public Version Status: Update
• Public Device Record Key: 1f5c8ba1-8e15-4fd0-a1f1-f6ec2cca933e
• Distribution End Date: 2022-08-10

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: 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MND	Ligator, esophageal	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17785	Endoscopic ligature loop	A device that is used to constrict a protruding tissue, e.g., a varix or a polyp to prevent or control bleeding following, e.g., a polypectomy, thereby creating a haemostasis or necrosis during an endoscopic procedure. It is applied using a dedicated endoscopic ligator. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170044953	GS1
Unit of Use	84953170044959	GS1

Customer Contacts

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