iovera Smart Tip

GUDID 00816287020279

SMART TIP, STIMULATING (1X90MM), 5-PACK

PACIRA CRYOTECH, INC.

Hand-held cryosurgical system handpiece tip

• Primary Device ID: 00816287020279
• NIH Device Record Key: ecf18c90-dc94-4073-8cc3-d54325af155d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iovera Smart Tip
• Version Model Number: STT2190STIM-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	00816287020279 [Unit of Use]
GS1	00816287020286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220656

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

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

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

Ethylene Oxide

[00816287020279]

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