FDA UDI
In Commercial Distribution
🇺🇸 United States
dermaPACE Console
DI: 00812265010218
·
Model: DEP0330
·
Sanuwave, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- dermaPACE Console
- Primary DI
- 00812265010218
- Version / Model
- DEP0330
- Company Name
- Sanuwave, Inc.
- Labeler DUNS
- 832217439
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 2
- Public Version Date
- 2021-07-08
- Public Version Status
- Update
- Public Device Record Key
- c201d920-1f57-4d79-b486-a533c5cdf2de
Device Description
Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | General, Plastic Surgery | 878.4685 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59043 | Dermatological extracorporeal shock wave therapy system | An assembly of devices designed to provide spark-gap-generated extracorporeal shock wave therapy (ESWT) intended to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds; cellulite). It typically consists of a generator that supplies the high voltage energy; and a hand-held, fluid-filled, shock wave applicator that produces spark-gap (electrohydraulic) energy delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually or from a pre-programmed radio-frequency identification (RFID) card. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812265010218 | GS1 |
Customer Contacts
- Phone
- 678-578-0108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160037 | 000 |