FDA.reportPublic FDA data

RHNO ROCKET WIDELINE NASAL PACK, LARGE (polyvinyl alcohol sponge)

Primary DI
00821925030350
Brand
RHNO ROCKET WIDELINE NASAL PACK, LARGE (polyvinyl alcohol sponge)
Company
Gyrus Acmi, Inc.
Model
70890756
Published
2018-09-13
Public version status
Update
Distribution status
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
00821925030350PackageGS16In Commercial Distribution
00821925037250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030350008219250303508219250303500821925030350
00821925037250008219250372508219250372500821925037250

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925000933Gyrus ACMI207142024-07-25
00821925025929DIEGO701390002024-07-25
00821925025936DIEGO701390022024-07-25
00821925025974DIEGO701390102024-07-25
00821925025967DIEGO701390082024-07-25
00821925000469Gyrus ACMI005-5-1012024-07-25
00821925000476Gyrus ACMI005-5-2012024-07-25
00821925000483Gyrus ACMI005-5-3012024-07-25
00821925000490Gyrus ACMI005-5-4012024-07-25
00821925010932Gyrus ACMI608BX2024-07-25
00821925025943DIEGO701390042024-07-25
00821925022379Gyrus ACMI8909122024-07-25
00821925010819Gyrus ACMI7035-30062024-07-25
00821925043077DIEGO ELITEBB4000SC2024-07-25
00821925043879SOLTIVETFL-FBX150S2024-07-25

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