Faller Stylet FS-401

GUDID 00792079000424

Medionics International Inc

Subcutaneous tunneller, single-use

• Primary Device ID: 00792079000424
• NIH Device Record Key: ce0f5480-df14-4059-a8ba-292a830c041d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faller Stylet
• Version Model Number: FS-401
• Catalog Number: FS-401
• Company DUNS: 241421320
• Company Name: Medionics International 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: 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: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com
• Phone: 905-472-6544
• Email: info@medionics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792079000424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130441

FDA Product Code

• FJS: Catheter, Peritoneal, Long-Term Indwelling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-09

On-Brand Devices [Faller Stylet]

• 00792079001223: FS-403
• 00792079001216: FS-402
• 00792079000424: FS-401