FDA.report

RELIEVA VORTEX 2

Primary DI
20705031205878
Company
ACCLARENT, INC.
Model
RV02
Catalog number
RV02
Device description
RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER
Published
2016-10-01
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

Related Records

Regulatory Flags

DUNS number
361092450
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20705031205878PackageGS15In Commercial Distribution
10705031205871PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20705031205878PackageGS15BOX10705031205871In Commercial Distribution
10705031205871PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KARIrrigator, Sinus1Ear, Nose, Throat874.4420NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Paranasal sinus irrigation catheterA sterile flexible tube designed to introduce fluid (e.g., saline solution) into the sinus cavities to provide irrigation for the flushing and removal of mucus, pus, and blood from the site of intervention. It typically consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected to a syringe or irrigation fluid pumping system via a Luer-lock. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)775-2789xx@xx.xx
+1(800)654-2873custsvcnj@integralife.com

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