TruDi NAV Suction TDNS000Z

GUDID 80705031245876

TruDi NAV Suction, 0° - 1PK

ACCLARENT, INC.

Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system
Primary Device ID80705031245876
NIH Device Record Key8c1ab2c3-4015-4367-8e31-eb5f67731eb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruDi NAV Suction
Version Model NumberTDNS000Z
Catalog NumberTDNS000Z
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
Phone+1(877)775-2789
Emailxxx@xxx.xxx
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
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
GS110705031245877 [Primary]
GS180705031245876 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGWEar, Nose, and Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[80705031245876]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

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

On-Brand Devices [TruDi NAV Suction]

80705031245890TruDi NAV Suction, 90° - 1PK
80705031245883TruDi NAV Suction, 70° - 1PK
80705031245876TruDi NAV Suction, 0° - 1PK

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