FDA.reportPublic FDA data

Silicone Nasal Epistaxis Balloon

Primary DI
14711182605473
Brand
Silicone Nasal Epistaxis Balloon
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
3102-2010
Published
2021-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMXBalloon, Epistaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14711182605473PrimaryGS10
04711182605476Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471118260547314711182605473
04711182605476047111826054764711182605476

GMDN Terms#

Term, Definition table
TermDefinition
Nasal haemostatic balloonA device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.

Regulatory Flags#

DUNS number
656763489
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14711182607989FixPad Anchoring Device1800-00052021-11-15
04710961933472Silicone Supra-Pubic Catheter (Ordinary Balloon)1857-02122016-03-15
04710961934127Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02122016-03-11
04710961934134Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02142016-03-11
04710961934141Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02162016-03-11
04710961934158Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02182016-03-11
04710961934165Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02202016-03-11
04710961934172Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02222016-03-11
04710961934189Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02242016-03-11
04710961934196Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82122016-03-15
04710961934202Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82142016-03-15
04710961934219Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82162016-03-15
04710961934226Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82182016-03-15
04710961934233Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-8220 2016-03-15
04710961934240Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82222016-03-15
04710961934257Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82242016-03-15
04710961937531Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02102016-03-15
04710961937548Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02122016-03-15
04710961937555Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02142016-03-15
04710961937562Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02162016-03-15

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