| Primary Device ID | 00850019947632 | 
| NIH Device Record Key | c42187d2-e42e-46bc-9758-a049cb9ef413 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Dermal Cooling System | 
| Version Model Number | M1-TIP3-20 | 
| Catalog Number | M1-TIP3-20 | 
| Company DUNS | 080023734 | 
| Company Name | R2 DERMATOLOGY INC. | 
| Device Count | 20 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| 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 | 
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | |
| Phone | +1(925)378-4400 | 
| info@r2technologies.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850019947632 [Unit of Use] | 
| GS1 | 00850019947847 [Primary] | 
| GS1 | 00850019947878 [Primary] | 
| GED | BRUSH, DERMABRASION, MANUAL | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-06-19 | 
| Device Publish Date | 2023-06-09 | 
| 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 |