FDA UDI
In Commercial Distribution
🇺🇸 United States
dermaPACE Applicator
DI: 00812265010201
·
Model: DAP0332
·
Sanuwave, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- dermaPACE Applicator
- Primary DI
- 00812265010201
- Version / Model
- DAP0332
- 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
- 1
- Public Version Date
- 2021-02-02
- Public Version Status
- New
- Public Device Record Key
- 5e388be3-4a58-4053-a21c-cda42c1c704e
Device Description
Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers
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
- 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 |
|---|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | General, Plastic Surgery | 878.4685 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59045 | Dermatological extracorporeal shock wave therapy system applicator | A hand-held component of a dermatological extracorporeal shock wave therapy (ESWT) system designed to transmit spark-gap-generated (electrohydraulic) shock waves to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; traumatic wounds; cellulite). It is connected to the system generator by a flexible conduit and has a fluid-filled head portion intended to be moved over the skin surface of the treatment area for application of the shock waves. It is typically used with a sterile drape during treatment of open wounds and requires a sterile transmission media (ultrasonic gel). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812265010201 | GS1 |
Customer Contacts
- Phone
- 678-578-0108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160037 | 000 |