FDA.report

Silicone Nasal Epistaxis Balloon

Primary DI
04711182605476
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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EMXBalloon, Epistaxis

Product Code Classifications

CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14711182605473PrimaryGS10
04711182605476Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471118260547314711182605473
04711182605476047111826054764711182605476

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
656763489
Device count
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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04710961934912Silicone C.W.V. Reservoir2013-09402022-01-31
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04710961935025Silicone Flat Drain2014-01322022-01-31
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