CarpX

Basic Information

• Brand Name: CarpX
• Primary DI: 00860004588009
• Version / Model: 260-03506
• Company Name: PAVMED INC.
• Labeler DUNS: 079825991
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-17
• Public Version: 1
• Public Version Date: 2020-08-25
• Public Version Status: New
• Public Device Record Key: c2e18d4c-1ecf-4357-aaa3-96ae03618e9a

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860004588009	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200559	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius