iovera

Basic Information

• Brand Name: iovera
• Primary DI: 00816287020071
• Version / Model: IST0221
• Company Name: Pacira Pharmaceuticals, Inc.
• Labeler DUNS: 117399934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-12
• Public Version: 3
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: 81bd0ce1-b5aa-45b4-888c-c4ea7b62c4ae

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXH	Device, Surgical, Cryogenic	Neurology	882.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60507	Hand-held cryosurgical system	A hand-held assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin, subcutaneous, and/or mucosal tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It typically includes a single-use or reusable handpiece with disposable application tip and cryogen cartridge (e.g., N2O cartridge), whereby the cryogen is delivered through the handpiece to the tip which is applied to tissues. It can be used for dedicated applications or across clinical specialties (e.g., general surgery, dermatology, neurology, orthopaedics, gynaecology).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816287020071	GS1

Premarket Submissions

Submission Number	Supplement Number
K173763	000