FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925034532
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
890911
Device description
POSTERIOR BALLOON CATHETER SILICONE
Published
2018-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00821925022362PackageGS16Not in Commercial Distribution
00821925034532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022362008219250223628219250223620821925022362
00821925034532008219250345328219250345320821925034532

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
007198742
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13
00821925037236Gyrus ACMI708907542018-09-13

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
08904428722075OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722082OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722099OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722105OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722112OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722129OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722136OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722143OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722150OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722167OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722174OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722181OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722198OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722204OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722211OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722228OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722235OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722242OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722259OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722266OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722273OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722280OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722297OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722303OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722310OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722327OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722334OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722341OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11