Marina Medical

Basic Information

• Brand Name: Marina Medical
• Primary DI: 00840306828126
• Version / Model: 300-169
• Catalog Number: 300-169
• Company Name: MARINA MEDICAL INSTRUMENTS, INC.
• Labeler DUNS: 011442279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2024-05-20
• Public Version: 1
• Public Version Date: 2024-05-28
• Public Version Status: New
• Public Device Record Key: 1e38bf44-ea56-4545-bf38-beb3adb54cc2

Device Description

Needle Electrode, Fine, Sterile, Single-Use, BOX40

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An 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 is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10840306828123	GS1
Primary	00840306828126	GS1

Customer Contacts

• Phone: [phone] ext. 115
• Email: [email protected]