Secca 175-5107

GUDID 00856219002003

Secca Handpiece and Accessory Kit for use only with the Mederi MDRF1 Generator

MEDERI THERAPEUTICS INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 00856219002003
• NIH Device Record Key: a2c5f49e-ce3a-4da1-9f60-f8c65723d420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Secca
• Version Model Number: 8000
• Catalog Number: 175-5107
• Company DUNS: 022785895
• Company Name: MEDERI THERAPEUTICS 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: 2039309980
• Email: mlucey@mederi-inc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856219002003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014216

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2016-09-27

Devices Manufactured by MEDERI THERAPEUTICS INC.

• 00856219002003 - Secca: 2018-07-06Secca Handpiece and Accessory Kit for use only with the Mederi MDRF1 Generator
• 00856219002003 - Secca: 2018-07-06 Secca Handpiece and Accessory Kit for use only with the Mederi MDRF1 Generator
• 00856219002102 - Mederi MDRF1 Generator: 2018-07-06 Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters
• 00856219002294 - Stretta: 2018-03-29 Stretta Catheter and Accessory Kit for use only with Mederi MDRF1 Generator