RELIEVA ULTIRRA BC0516RU

GUDID 20705031200255

RELIEVA ULTIRRA SINUS BALLOON CATHETER 5x16

ACCLARENT, INC.

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter
Primary Device ID20705031200255
NIH Device Record Key861b644e-6334-405b-b721-15a02c48afbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameRELIEVA ULTIRRA
Version Model NumberBC0516RU
Catalog NumberBC0516RU
Company DUNS361092450
Company NameACCLARENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx
Phone+1(650)687-5888
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031200258 [Primary]
GS120705031200255 [Package]
Contains: 10705031200258
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRCINSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-22
Device Publish Date2016-10-01

On-Brand Devices [RELIEVA ULTIRRA]

20705031200293RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x24
20705031200286RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x16
20705031200279RELIEVA ULTIRRA SINUS BALLOON CATHETER 6x16
20705031200255RELIEVA ULTIRRA SINUS BALLOON CATHETER 5x16

Trademark Results [RELIEVA ULTIRRA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RELIEVA ULTIRRA
RELIEVA ULTIRRA
85393116 4227217 Live/Registered
ACCLARENT, INC.
2011-08-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.