FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermal Cooling System
DI: 00850019947182
·
Model: M1-SC-FR1-100-1
·
R2 DERMATOLOGY INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dermal Cooling System
- Primary DI
- 00850019947182
- Version / Model
- M1-SC-FR1-100-1
- Catalog Number
- M1-SC-FR1-100-1
- Company Name
- R2 DERMATOLOGY INC.
- Labeler DUNS
- 080023734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- dc51776c-0e6f-47ca-aa6c-b9083974e1df
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEH | UNIT, CRYOSURGICAL, ACCESSORIES | General, Plastic Surgery | 878.4350 | 2 |
| MLY | REFRIGERANT, TOPICAL (VAPOCOOLANT) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62814 | General cryosurgical system, thermo-electric cooler | An assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019947182 | GS1 |
Customer Contacts
- Phone
- +1(925)378-4400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201260 | 000 |