TruDi Shaver Blade TSB440Z

GUDID 20705031469263

Trudi Shaver Blade 4.0mm - 40° Curved - 1pk

ACCLARENT, INC.

Metal/carbide ENT bur, single-use

• Primary Device ID: 20705031469263
• NIH Device Record Key: 50d7c6f4-8545-408e-a6a4-99d08e0fad97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDi Shaver Blade
• Version Model Number: TSB440Z
• Catalog Number: TSB440Z
• 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: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx
• 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
• 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
• 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	20705031469263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221037

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

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: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [TruDi Shaver Blade]

• 20705031469300: Trudi Shaver Blade 4.0mm - 60° Curved - 1pk
• 20705031469287: Trudi Shaver Blade 4.0mm - 15° Curved - 1pk
• 20705031469263: Trudi Shaver Blade 4.0mm - 40° Curved - 1pk
• 20705031469256: Trudi Shaver Blade 3.0mm - Straight (0°)- 1pk
• 20705031469225: Trudi Shaver Blade 4.0mm - Straight (0°)- 1pk
• 20705031469294: Trudi Shaver Blade 4.0mm - 15° Curved - 5pk
• 20705031469270: Trudi Shaver Blade 4.0mm - 40° Curved - 5pk
• 20705031469249: Trudi Shaver Blade 3.0mm - Straight (0°)- 5pk
• 20705031469232: Trudi Shaver Blade 4.0mm - Straight (0°)- 5pk
• 20705031469218: Trudi Shaver Blade 4.0mm - 60° Curved - 5pk