TruDi NAV Suction TDNS070Z

GUDID 10705031245884

TruDi NAV Suction, 70° - 1PK

ACCLARENT, INC.

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 10705031245884
• NIH Device Record Key: 7b2915ae-f07e-47c3-8358-8475eab63e97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDi NAV Suction
• Version Model Number: TDNS070Z
• Catalog Number: TDNS070Z
• Company DUNS: 361092450
• Company Name: ACCLARENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031245884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180948

FDA Product Code

• PGW: Ear, Nose, and Throat Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10705031245884]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-11-21
• Device Publish Date: 2019-01-20

On-Brand Devices [TruDi NAV Suction]

• 80705031245890: TruDi NAV Suction, 90° - 1PK
• 80705031245883: TruDi NAV Suction, 70° - 1PK
• 80705031245876: TruDi NAV Suction, 0° - 1PK
• 10705031245891: TruDi NAV Suction, 90° - 1PK
• 10705031245884: TruDi NAV Suction, 70° - 1PK
• 10705031245877: TruDi NAV Suction, 0° - 1PK