FDA UDI
In Commercial Distribution
🇺🇸 United States
UreTron Generator
DI: 00854732006003
·
Model: URT-G-US
·
Ultratellege USA Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UreTron Generator
- Primary DI
- 00854732006003
- Version / Model
- URT-G-US
- Company Name
- Ultratellege USA Co., Ltd.
- Labeler DUNS
- 118825182
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 15c1b213-8631-47ae-80e1-a049328e0f04
Device Description
UreTron Lithotripter Generator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | 876.4480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47099 | Pneumatic/ultrasonic lithotripsy system control unit | A mains electricity (AC-powered) component of a pneumatic/ultrasonic intracorporeal lithotripsy system designed to regulate the energy delivered to fragment the stones (i.e., renal, ureteral, urethral, and bladder calculi) for their removal. It is typically connected to a supply of hospital grade compressed air (pipeline/compressor) and has a twin function: 1) to provide and regulate the pneumatic pressure pulses which propagate to the distal tip of the mechanical probe via its handpiece; and 2) to deliver and control electrical energy to the ultrasonic handpiece and its probe. It may also facilitate the removal of the calculi via a suction system and fragmented stone catcher. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854732006003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160198 | 000 |