Marina Medical

Basic Information

• Brand Name: Marina Medical
• Primary DI: 00840306805448
• Version / Model: 200-320
• Catalog Number: 200-320
• Company Name: MARINA MEDICAL INSTRUMENTS, INC.
• Labeler DUNS: 011442279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-08
• Public Version: 2
• Public Version Date: 2022-12-12
• Public Version Status: Update
• Public Device Record Key: bf17ac46-4e1f-4cc3-803e-08edd2babd04

Device Description

Beyer Bone Rongeur, Double Action, Cup Size 2.5mm x 20mm, Length: 18 cm / 7 in

Device Characteristics

• Single Use: No
• 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: MR Safe
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KBB	RONGEUR, NASAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33442	Craniofacial rongeur, reusable	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840306805448	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7	Inch