FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermal Cooling System
DI: 00850019947564
·
Model: M1-TIP1-10
·
R2 DERMATOLOGY INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Dermal Cooling System
- Primary DI
- 00850019947564
- Version / Model
- M1-TIP1-10
- Catalog Number
- M1-TIP1-10
- Company Name
- R2 DERMATOLOGY INC.
- Labeler DUNS
- 080023734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 563eb4f8-eff3-4dfb-8ab5-4e2e009301c1
Device Description
Dermal Cooling System smooth tip
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| ILO | Pack, hot or cold, water circulating | Physical Medicine | 890.5720 | 2 |
| QPZ | Contact cooling for skin lesion pain relief | General, Plastic Surgery | 878.4340 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850019947991 | GS1 | ||||
| Primary | 00850019947564 | GS1 |
Customer Contacts
- Phone
- +1(925)378-4400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213294 | 000 |