| 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 |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com | |
| Phone | +1(925)378-4400 |
| info@r2derm.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B563HP0040 [Primary] |
| GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2019-08-20 |
| 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 |