FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306821684
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
189-904
Catalog number
189-904
Device description
Rhizotomy; set 2 (un-coated)
Published
2024-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXXPROBE, RECTAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306821684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306821684008403068216848403068216840840306821684

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, denervation, monopolar, reusableA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags#

DUNS number
011442279
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840306837388Marina Medical200-281200-2812026-05-11
00840306837395Marina Medical200-280200-2802026-05-11
00840306811586Marina Medical110-671L110-671L2024-01-30
00840306811654Marina Medical110-689L110-689L2024-01-30
00840306811661Marina Medical110-800110-8002024-01-30
00840306837364Marina Medical050-182CER050-182CER2026-04-15
00840306837371Marina Medical050-701CER050-701CER2026-04-15
00840306837272Marina Medical33725-1733725-172025-09-03
00840306837289Marina Medical33727-1733727-172025-09-03
00840306837333Marina Medical99-76099-7602026-02-18
00840306837340Marina Medical050-335SCE050-335SCE2026-02-18
00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
00840306824579Marina Medical222-222222-2222024-05-01
00840306835919Marina Medical800-935800-9352024-12-10
00840306835940Marina Medical800-943800-9432024-12-11
00840306835933Marina Medical800-941800-9412024-10-22
00840306835551Marina Medical800-400-05800-400-052024-10-11
00840306834479Marina Medical521-055521-0552024-09-19
00840306834516Marina Medical522-055522-0552024-09-19
00840306834523Marina Medical522-360522-3602024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613026622MSI Precision Specialty InstrumentsMed Saver, Inc.EXX2025-08-01
04049047024408GimmiGimmi GmbHEXX2025-04-16
04049047024477GimmiGimmi GmbHEXX2025-04-16
00840306830778Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-19
00840306830341Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830358Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830365Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840183526962BR Surgical, LLCBR Surgical, LLCEXX2024-05-29
00840306826832Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-05-10
00840306824166Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-29
00840306821691Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306806728Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
00840306807336Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
G586UR96105210Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR96105610Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR6105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105530Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105540Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
00860001161618GreenEggEndoglow, LLCEXX2023-07-07
00840306808258Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00840306808326Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00842331181887Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331185564Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331152450Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331155468Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331131493Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331133619Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331135583Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331136306Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10