Marina Medical

Basic Information

• Brand Name: Marina Medical
• Primary DI: 00840306827525
• Version / Model: 289-405
• Catalog Number: 289-405
• Company Name: MARINA MEDICAL INSTRUMENTS, INC.
• Labeler DUNS: 011442279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-16
• Public Version: 2
• Public Version Date: 2025-01-17
• Public Version Status: Update
• Public Device Record Key: 1dccd9dd-7ce3-4b25-aad0-494659156067

Device Description

Silicone Carving Block, Non-Sterile 7.5 x 15 x 2cm, 10 Durometer (Soft), Clear

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNR	BLOCK, CUTTING, ENT, NON-STERILE	Ear, Nose, Throat	874.3540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58387	Surgical cutting/shaping board, reusable	A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840306827525	GS1

Customer Contacts

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