Juicebox J100

GUDID 00851354004073

Juicebox is an optional accessory to facilitate catheter tip rotation when using a compatible Avinger catheter. It consists of a handle with a Rotation Toggle Switch and a Release Button. Juicebox is designed to be placed over the catheter handle. This accessory is irradiated for sterility and is intended for single use only. When Juicebox is properly placed over a catheter handle, it locks into place. Depressing the Rotation Toggle Switch activates the power for rotation in either the clockwise or counterclockwise directions. The Release Button releases Juicebox so that it can be removed from the catheter handle.The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.

AVINGER, INC.

Torque manipulation device

• Primary Device ID: 00851354004073
• NIH Device Record Key: 51767dc1-f1ef-4a10-897c-b2135df31460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Juicebox
• Version Model Number: J100
• Catalog Number: J100
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: 650-241-7030
• Email: tlawson@avinger.com
• Phone: 650-241-7030
• Email: tlawson@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111704

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[00851354004073]

Radiation Sterilization

[00851354004073]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

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