FDA.reportPublic FDA data

Marina Medical

Primary DI
00840306824289
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
220-104
Catalog number
220-104
Device description
Van Buren Urethral Sound, 16Fr, 28cm
Published
2024-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840306824289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306824289008403068242898403068242890840306824289

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Centimeter

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840306837333Marina Medical99-76099-7602026-02-18
00840306837340Marina Medical050-335SCE050-335SCE2026-02-18
00840306837357Marina Medical050-472SCE050-472SCE2026-02-18
00840306837272Marina Medical33725-1733725-172025-09-03
00840306837289Marina Medical33727-1733727-172025-09-03
00840306837203Marina Medical1575-CCS16301575-CCS16302025-08-08
00840306837210Marina Medical1575-CCS18301575-CCS18302025-08-08
00840306837227Marina Medical1570-BR21570-BR22025-08-08
00840306837234Marina Medical1570-BR31570-BR32025-08-08
00840306837241Marina Medical1570-BR51570-BR52025-08-08
00840306837258Marina Medical1570-BR61570-BR62025-08-08
00840306837265Marina Medical1570-BR101570-BR102025-08-08
00840306837180Marina Medical110-346110-3472025-07-02
00840306837197Marina Medical110-347110-3472025-07-02
00840306837173Marina Medical050-964050-9642025-06-04
00840306805882Marina MedicalR642.07R642.072025-04-04
00840306812026Marina Medical180-140180-1402025-03-12
00840306830938Marina Medical20-017020-01702025-03-12
00840306830945Marina Medical20-017420-01742025-03-12
00840306836466Marina Medical200-262200-2622025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613046514MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100438MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100766MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103057MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103552MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104238MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104993MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613105587MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106614MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106942MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115913MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115920MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115937MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00190776394189MillenniumAvalign Technologies, Inc.FBX2025-05-07
00190776394196MillenniumAvalign Technologies, Inc.FBX2025-05-07
00840183530037BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530044BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530051BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530068BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530075BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530082BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530099BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530020BR Surgical, LLCBR Surgical, LLCFBX2025-04-15
00840183529789BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00840183529864BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00194613046507MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613100773MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613103545MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613104221MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613105006MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21