PowerWire Radiofrequency GuideWire Kit

Basic Information

• Brand Name: PowerWire Radiofrequency GuideWire Kit
• Primary DI: 07540299000235
• Version / Model: EWK35-250-12-6A-30-05
• Company Name: Baylis Medical Technologies Inc
• Labeler DUNS: 240389677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 2
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: a077b4ba-b652-4a87-a25b-6230db5a03da

Device Description

PowerWire RF GuideWire; RFP-100A Connector Cable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• 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
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540299000235	GS1
Previous	00685447001072	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101615	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			110 angled 30K 250cm PowerWire RF GuideWire with OD = 0.035 in, distal taper = 6cm and 5 marker bands placed 1cm apart; 3m RFP-100A Connector Cable