ICEOUT™ CRY25

GUDID 10607151012127

ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATORS

ASPEN SURGICAL PRODUCTS, INC.

Cryogenic spray, cutaneous

• Primary Device ID: 10607151012127
• NIH Device Record Key: 001bbeb3-d70d-4ea6-b077-81c9bc617445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICEOUT™
• Version Model Number: CRY25
• Catalog Number: CRY25
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL PRODUCTS, 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Exposed to temperatures exceeding 20 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Exposed to temperatures exceeding 20 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607151012127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152203

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-12-30
• Device Publish Date: 2017-08-17

On-Brand Devices [ICEOUT™]

• 10607151012127: ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATOR
• 10607151012110: ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS 2 CANS AND (50) 5 MM APPLICATO
• 10607151012103: ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2 MM APPLICATORS