iovera Smart Tip

Basic Information

• Brand Name: iovera Smart Tip
• Primary DI: 00816287020187
• Version / Model: STT0801-5
• Company Name: Pacira Pharmaceuticals, Inc.
• Labeler DUNS: 117399934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-06-15
• Public Version: 2
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: e1b604f6-8bc2-42b1-b299-2d19f8a8b94e

Device Description

SMART TIP (1X90MM), 5-PACK

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: 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
60508	Hand-held cryosurgical system handpiece tip	A sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816287020170	GS1
Primary	00816287020187	GS1

Premarket Submissions

Submission Number	Supplement Number
K173763	000