FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
DI: 00811779030002
·
Model: P3000002
·
UNITED MEDICAL SYSTEMS (DE), INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
- Primary DI
- 00811779030002
- Version / Model
- P3000002
- Company Name
- UNITED MEDICAL SYSTEMS (DE), INC.
- Labeler DUNS
- 002329923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-26
- Public Version
- 4
- Public Version Date
- 2018-10-26
- Public Version Status
- Update
- Public Device Record Key
- eee1bb54-a157-4fb7-b9c2-72e71c33c0b7
- Distribution End Date
- 2018-03-01
Device Description
Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of calculi located in the kidneys and urinary tract. Comprised of ESWL control unit, Litho arm for Philips BV Pulsera c-arm, Philips BV Pulsera x-ray, Sonoace X6 Ultrasound, Oakworks CFLU401 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 |
|---|---|---|---|---|---|---|
| Primary | 00811779030002 | GS1 |
Customer Contacts
- Phone
- 5088706565
- [email protected]