TruDi NAVWIRE TDNW001

GUDID 20705031245904

TruDi NAVWIRE Sinus Navigation Guidewire - 5PK

ACCLARENT, INC.

Paranasal sinus guidewire
Primary Device ID20705031245904
NIH Device Record Key41ee40d1-cdf3-4413-8342-ff2216991d51
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruDi NAVWIRE
Version Model NumberTDNW001
Catalog NumberTDNW001
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031245907 [Primary]
GS120705031245904 [Package]
Contains: 10705031245907
Package: Box [5 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-22
Device Publish Date2019-10-20

On-Brand Devices [TruDi NAVWIRE]

20705031245911TruDi NAVWIRE Sinus Navigation Guidewire - 1PK
20705031245904TruDi NAVWIRE Sinus Navigation Guidewire - 5PK

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