CryOmega 800-2001

GUDID 10850077006033

The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.

CRYOCONCEPTS, LP

Cryogenic spray, cutaneous

• Primary Device ID: 10850077006033
• NIH Device Record Key: 29a6ae37-5011-445a-8d9d-2b5228881041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryOmega
• Version Model Number: 800-2001
• Catalog Number: 800-2001
• Company DUNS: 038024868
• Company Name: CRYOCONCEPTS, LP
• 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: true
• 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

Customer Support Contacts

• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com

Device Dimensions

• Weight: 8 Gram

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077006036 [Primary]
GS1	10850077006033 [Package]; Contains: 00850077006036; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102006

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [CryOmega]

• 10850077006033: The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap
• 10850077006002: The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap
• 00850077006210: The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap