iovera

GUDID 00816287020248

SYSTEM FALCON IOVERA US

PACIRA CRYOTECH, INC.

General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic 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