ACCLARENT PIVOT PVT0616NZ

GUDID 20705031465609

ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK

ACCLARENT, INC.

Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use
Primary Device ID20705031465609
NIH Device Record Keyeb04089f-83b1-4194-a46c-21692f4e5fb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCLARENT PIVOT
Version Model NumberPVT0616NZ
Catalog NumberPVT0616NZ
Company DUNS361092450
Company NameACCLARENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx
Phone+1(650)687-5888
Emailxxx@xxx.xxx

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS120705031465609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGWEar, Nose, and Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01

On-Brand Devices [ACCLARENT PIVOT]

20705031465616ACCLARENT PIVOT Balloon Dilation System - 1PK
20705031465609ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK
20705031465586ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK
20705031465593ACCLARENT PIVOT Navigation Balloon Dilation System
20705031465579ACCLARENT PIVOT Illumination Balloon Dilation System
20705031465562ACCLARENT PIVOT Balloon Dilation System

Trademark Results [ACCLARENT PIVOT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCLARENT PIVOT
ACCLARENT PIVOT
88873621 not registered Live/Pending
Acclarent, Inc.
2020-04-15

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