ezSnare Polypectomy Snare

Basic Information

• Brand Name: ezSnare Polypectomy Snare
• Primary DI: 00816207021607
• Version / Model: ET1803
• Catalog Number: ET1803
• Company Name: ENDO-THERAPEUTICS, INC.
• Labeler DUNS: 825239189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-29
• Public Version: 1
• Public Version Date: 2021-02-08
• Public Version Status: New
• Public Device Record Key: 8028d6b7-0517-469a-ad59-2a6f325e138f

Device Description

Endoscopic Polypectomy Snare, Extra Large Oval - Hot

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816207021604	GS1	box	10	In Commercial Distribution
Primary	00816207021607	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Loop Size Oval 30 mm
Device Size Text, specify			Min Channel 2.0 mm
Outer Diameter	1.7	Millimeter
Length	150	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry