FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraMIST Treatment Wand
DI: 00812265010324
·
Model: CP-80033
·
Sanuwave, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UltraMIST Treatment Wand
- Primary DI
- 00812265010324
- Version / Model
- CP-80033
- 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
- cbd2aacb-df3a-4581-86e9-e8d7d0c3b48d
Device Description
Component to the UltraMIST System
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 |
|---|---|---|---|---|
| NRB | Wound Cleaner, Ultrasound | General, Plastic Surgery | 878.4410 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62138 | Wound therapy ultrasound system | A portable assembly of mains electricity (AC-powered) devices intended to deliver low frequency ultrasound (US) energy, via a fluid mist, to a wound (e.g., skin wound, burn, deep tissue injury, diabetic foot ulcer) to promote healing of the wound without direct wound contact. It consists of a radio-frequency (RF) generator with a fluid pump, handpiece that transduces RF to US, handpiece tip, and appropriate tubing intended to be used with a fluid solution (e.g., saline). The ultrasound-conductive mist is directed at the wound site and intended to remove fibrin, yellow slough, tissue exudates, and bacteria. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812265010324 | GS1 | ||||
| Previous | 00816789010204 | GS1 |
Customer Contacts
- Phone
- 678-578-0108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140782 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius