CryoClear 801-2001

GUDID 00850077006050

The CryoClear™ is a multi-use disposable device intended for the removal 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. • Lentigo (Age Spots) • Skin Tags • Actinic Keratosis (Sun Spots) • Acne (Cysts & Scars) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia

CRYOCONCEPTS, LP

Cryogenic spray, cutaneous

• Primary Device ID: 00850077006050
• NIH Device Record Key: 8020b0c8-1736-4c80-a365-648501338df2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoClear
• Version Model Number: 801-2001
• Catalog Number: 801-2001
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store the device away from heat or potential sources of heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device away from heat or potential sources of heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device away from heat or potential sources of heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device away from heat or potential sources of heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077006050 [Primary]
GS1	10850077006057 [Package]; 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 [CryoClear]

• 00850077006050: The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by a
• 00850077006043: The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by a