FDA.reportPublic FDA data

Epistax Balloon Catheter

Primary DI
00385640000321
Brand
Epistax Balloon Catheter
Company
Summit Medical, Inc.
Model
RH-4200-10
Catalog number
RH-4200-10
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10385640000328PackageGS110In Commercial Distribution
00385640000321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564000032810385640000328
00385640000321003856400003213856400003210385640000321

GMDN Terms#

Term, Definition table
TermDefinition
Epistaxsis 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
888-229-2875customerservice@summitmedicalusa.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640094535INSTRUSAFEIN-2020-77912026-09-24
00385640094542INSTRUSAFEIN-2020-77902026-09-24
00385640094559INSTRUSAFEIN-2020-81222026-09-24
00385640094511INSTRUSAFEIN-2020-81842026-09-22
00385640094528INSTRUSAFEIN-2020-82632026-09-22
00385640094504INSTRUSAFEIN-2020-81892026-09-21
00385640094146INSTRUSAFEIN-2020-81562026-08-27
00385640094153INSTRUSAFEIN-2020-81182026-08-27
00385640094160INSTRUSAFEIN-2020-46252026-08-27
00385640094177INSTRUSAFEIN-2020-80712026-08-27
00385640094139INSTRUSAFEIN-2020-80552026-08-26
00385640094108INSTRUSAFEIN-2020-80222026-08-25
00385640094115INSTRUSAFEIN-2020-79442026-08-25
00385640094122INSTRUSAFEIN-2020-81962026-08-25
00385640094030INSTRUSAFEIN-2020-72762026-08-21
00385640094047INSTRUSAFEIN-2020-79432026-08-21
00385640094054INSTRUSAFEIN-2020-81902026-08-21
00385640094061INSTRUSAFEIN-8701-NF2026-08-21
00385640094078INSTRUSAFEIN-8701-R2026-08-21
00385640094085INSTRUSAFEIN-8701-TF2026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925034662Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925042391Gyrus ACMIGyrus ACMI, LLCEMX2024-07-25
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08904428722129OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
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08904428722327OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722334OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722341OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11