CarpX

GUDID 00860004588009

The PAVmed CarpX is a sterile, single-use, bipolar high frequency electrosurgical device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during minimally invasive or general surgical procedures for tissue cutting, including the isolation and division of ligaments, tendons and fascia such as the transverse carpal ligament for the treatment of carpal tunnel syndrome.

PAVMED INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00860004588009
• NIH Device Record Key: c2e18d4c-1ecf-4357-aaa3-96ae03618e9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarpX
• Version Model Number: 260-03506
• Company DUNS: 079825991
• Company Name: PAVMED 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com
• Phone: 212-949-4319
• Email: info@pavmed.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004588009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200559

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-08-25
• Device Publish Date: 2020-08-17