FDA.report

Marina Medical

Primary DI
00840306822360
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
190-295NC
Catalog number
190-295NC
Device description
Killian Nasal Speculum, NC, Narrow Blades, Full,Internal Groove, 75mm, Blade 14cm
Published
2024-04-10
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

Related Records

Contact Domains

Product Codes

CodeName
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications

CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306822360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306822360008403068223608403068223600840306822360

GMDN Terms

TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Device Sizes

TypeValueUnit
Length14Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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

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