FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermal Cooling System
DI: B563C20010
·
Model: C2-001
·
R2 Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dermal Cooling System
- Primary DI
- B563C20010
- Version / Model
- C2-001
- Catalog Number
- C2-001
- Company Name
- R2 Technologies, Inc.
- Labeler DUNS
- 080023734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 6
- Public Version Date
- 2024-11-19
- Public Version Status
- Update
- Public Device Record Key
- 2f5f6e03-ff74-42e2-b059-ee37005b3bc4
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.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
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 | B563C20010 | HIBCC |
Customer Contacts
- Phone
- +1(925)378-4400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171398 | 000 |