iovera Smart Tip

GUDID 00816287020200

SMART TIP (1X90MM), 5-PACK

PACIRA CRYOTECH, INC.

Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip Hand-held cryosurgical system handpiece tip

• Primary Device ID: 00816287020200
• NIH Device Record Key: 7e1e5312-72d2-419b-b250-f5223b5d928c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iovera Smart Tip
• Version Model Number: STT2190-5
• Company DUNS: 799347229
• Company Name: PACIRA CRYOTECH, INC.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00816287020200 [Unit of Use]
GS1	00816287020217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211334

FDA Product Code

• GXH: Device, Surgical, Cryogenic

Sterilization

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

[00816287020200]

Ethylene Oxide

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[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

[00816287020200]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [iovera Smart Tip]

• 00816287020279: SMART TIP, STIMULATING (1X90MM), 5-PACK
• 00816287020224: SMART TIP (3X8.5MM), 5-PACK
• 00816287020200: SMART TIP (1X90MM), 5-PACK
• 00816287020170: SMART TIP (1X90MM), 5-PACK
• 00816287020132: SMART TIP (3X8.5MM), 5-PACK
• 00816287020101: SMART TIP, STIMULATING (1X90MM), 5-PACK