Dermal Cooling System HP-004

GUDID B563HP0040

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.

R2 DERMATOLOGY INC.

General cryosurgical system, thermo-electric cooler

• Primary Device ID: B563HP0040
• NIH Device Record Key: 4821e8b2-44ff-4674-8e15-1df03f98d971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermal Cooling System
• Version Model Number: HP-004
• Catalog Number: HP-004
• 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@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com
• Phone: +1(925)378-4400
• Email: info@r2derm.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B563HP0040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171398

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: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2019-08-20

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