TruDi Probe TDP0705

GUDID 20705031464206

TruDi Probe-70deg - 5PK

ACCLARENT, INC.

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 20705031464206
• NIH Device Record Key: c23c4291-2059-4065-8745-f0d547bbaf7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDi Probe
• Version Model Number: TDP0705
• Catalog Number: TDP0705
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com
• Phone: +1(650)687-5888
• Email: xxx@xxx.com

Device Dimensions

• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree
• Angle: 70 degree

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
• 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	10705031464209 [Primary]
GS1	20705031464206 [Package]; Contains: 10705031464209; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193453

FDA Product Code

• PGW: Ear, Nose, and Throat Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [TruDi Probe]

• 20705031464220: TruDi Probe, 70°, 5in - 1PK
• 20705031464213: TruDi Probe, 0°, 5in - 1PK
• 20705031464206: TruDi Probe-70deg - 5PK
• 20705031464190: TruDI Probe 0-Degree - 5PK