Rezūm Accessory Kit

Basic Information

• Brand Name: Rezūm Accessory Kit
• Primary DI: 00855357006034
• Version / Model: D2202
• Company Name: NXTHERA, INC.
• Labeler DUNS: 947824194
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-17
• Public Version: 5
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: 75af2d7c-dfb4-4475-8e79-d388cd4fc994
• Distribution End Date: 2018-10-24

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: MR Safe
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855357006041	GS1	Box	5	Not in Commercial Distribution	2018-10-24
Primary	00855357006034	GS1

Customer Contacts

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