AxoTrack I Sterile Procedure Kit P22506

GUDID 30841517100156

Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

FUJIFILM SONOSITE, INC.

Ultrasound/electromagnetic-guided needle kit

• Primary Device ID: 30841517100156
• NIH Device Record Key: 5ac7b1a2-9bdc-4bb6-ab9c-7ada77e288f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxoTrack I Sterile Procedure Kit
• Version Model Number: P22506-02
• Catalog Number: P22506
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(999)999-9999
• Email: xyz@xyz.com
• Phone: +1(999)999-9999
• Email: xyz@xyz.com

Device Dimensions

• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months
• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months
• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months
• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months
• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months
• Special Storage Condition, Specify: Between 0 and 0 *Shelf Life = 36 months

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100155 [Primary]
GS1	30841517100156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113680

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

On-Brand Devices [AxoTrack I Sterile Procedure Kit]

• 30841517100156: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultras
• 00841517100162: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultras