iovera

GUDID 00816287020248

SYSTEM FALCON IOVERA US

PACIRA CRYOTECH, INC.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00816287020248
• NIH Device Record Key: bb5d0f18-4634-4f83-bda0-0f436258a014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iovera
• Version Model Number: IST2221
• Company DUNS: 799347229
• Company Name: PACIRA CRYOTECH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816287020248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211334

FDA Product Code

• GXH: Device, Surgical, Cryogenic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by PACIRA CRYOTECH, INC.

• 00816287020101 - iovera Smart Tip: 2023-06-23 SMART TIP, STIMULATING (1X90MM), 5-PACK
• 00816287020132 - iovera Smart Tip: 2023-06-23 SMART TIP (3X8.5MM), 5-PACK
• 00816287020170 - iovera Smart Tip: 2023-06-23 SMART TIP (1X90MM), 5-PACK
• 00816287020200 - iovera Smart Tip: 2023-06-23 SMART TIP (1X90MM), 5-PACK
• 00816287020224 - iovera Smart Tip: 2023-06-23 SMART TIP (3X8.5MM), 5-PACK
• 00816287020279 - iovera Smart Tip: 2023-06-23 SMART TIP, STIMULATING (1X90MM), 5-PACK
• 00816287020248 - iovera: 2023-06-21SYSTEM FALCON IOVERA US
• 00816287020248 - iovera: 2023-06-21 SYSTEM FALCON IOVERA US