Surgitie

Basic Information

• Brand Name: Surgitie
• Primary DI: 10884521099647
• Version / Model: EL-20-L
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 5
• Public Version Date: 2023-03-06
• Public Version Status: Update
• Public Device Record Key: f82def0f-1ea1-45a9-b550-299883c94858

Device Description

Ligating Loop with Delivery System

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: 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
GAL	SUTURE, ABSORBABLE, NATURAL	General, Plastic Surgery	878.4830	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
Package	20884521099644	GS1	CASE	6	In Commercial Distribution
Primary	10884521099647	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K904588	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			diameter,2/0,N/A;

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 130 Degrees Fahrenheit