RELIEVA TRACT RT1240A

GUDID 20705031462608

RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM

ACCLARENT, INC.

Nasal/paranasal balloon catheter
Primary Device ID20705031462608
NIH Device Record Keya9ee0023-9995-429c-8ee0-d2b058071adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRELIEVA TRACT
Version Model NumberRT1240A
Catalog NumberRT1240A
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(877)775-2789
Emailxxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031462601 [Primary]
GS120705031462608 [Package]
Contains: 10705031462601
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QGKBalloon, nasal airway

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-22
Device Publish Date2019-05-31

On-Brand Devices [RELIEVA TRACT]

20705031462653RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK
20705031462639RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM - 1PK
20705031462615RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM - 1PK
20705031462592RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM - 1PK
20705031462646RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM
20705031462622RELIEVA TRACT BALLOON DILATION SYSTEM, 14X40MM
20705031462608RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM
20705031462585RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM

Trademark Results [RELIEVA TRACT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RELIEVA TRACT
RELIEVA TRACT
88298874 not registered Live/Pending
Acclarent, Inc.
2019-02-12

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