FDA UDI
In Commercial Distribution
🇺🇸 United States
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
DI: 00810000980697
·
Model: P3000002
·
UNITED SERVICE SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
- Primary DI
- 00810000980697
- Version / Model
- P3000002
- Company Name
- UNITED SERVICE SOLUTIONS, LLC
- Labeler DUNS
- 117300115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-29
- Public Version
- 1
- Public Version Date
- 2020-02-06
- Public Version Status
- New
- Public Device Record Key
- f0308926-eaf0-4b5e-9e28-0718a5f84133
Device Description
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table
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 |
|---|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | Gastroenterology, Urology | 876.5990 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18416 | Piezoelectric lithotripsy system | An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator. This generator contains an array of up to 4,000 ceramic elements arranged on a spherical dish; shock waves are generated at the focal point of the dish when a short, high-voltage pulse is simultaneously applied to each element. This system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00810000980178 | GS1 | ||||
| Primary | 00810000980697 | GS1 |
Customer Contacts
- Phone
- 6142988150
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072538 | 000 |