Rotator

Basic Information

• Brand Name: Rotator
• Primary DI: 00724995182649
• Version / Model: 00711120
• Catalog Number: 00711120
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 2
• Public Version Date: 2020-11-10
• Public Version Status: Update
• Public Device Record Key: 397ec5cb-e7c9-4a91-9343-252bf489466e

Device Description

The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.

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: Yes
• 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
FDI	SNARE, FLEXIBLE	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	10724995182646	GS1	Case	10	In Commercial Distribution
Primary	00724995182649	GS1
Previous	00816765011010	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	230	Centimeter
Width	3	Centimeter
Outer Diameter	2.4	Millimeter

Storage Conditions

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