FDA.reportPublic FDA data

Rapid Rhino

Primary DI
20817470006616
Brand
Rapid Rhino
Company
Smith & Nephew, Inc.
Model
RR 450
Catalog number
RR 450
Device description
4.5CM ANTERIOR
Published
2015-08-29
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

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
20817470006616PackageGS110In Commercial Distribution
00817470006612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081747000661620817470006616
00817470006612008174700066128174700066120817470006612

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
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
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
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25

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