Dermal Cooling System M1-HP-007-00

GUDID 00850019947014

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. benign lesions of the skin.

R2 DERMATOLOGY INC.

General cryosurgical system, thermo-electric cooler

• Primary Device ID: 00850019947014
• NIH Device Record Key: 938ac737-05e5-4830-9539-e20a7acd5278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermal Cooling System
• Version Model Number: HP-005
• Catalog Number: M1-HP-007-00
• Company DUNS: 080023734
• Company Name: R2 DERMATOLOGY 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: false
• Serial Number: true
• 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(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com
• Phone: +1(925)378-4400
• Email: info@r2technologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019947014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201260

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [Dermal Cooling System]

• B563HP0030: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0020: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563C20010: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0050: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• B563HP0040: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947182: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947014: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947007: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947533: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947045: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur
• 00850019947632: Dermal Cooling System dermabrasion tip
• 00850019947991: Dermal Cooling System smooth tip