FDA UDI
In Commercial Distribution
🇺🇸 United States
Swiss LithoClast Select
DI: 07613353116071
·
Model: FT-148UH
·
E.M.S. Electro Medical Systems S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Swiss LithoClast Select
- Primary DI
- 07613353116071
- Version / Model
- FT-148UH
- Catalog Number
- M006840701UH0
- Company Name
- E.M.S. Electro Medical Systems S.A.
- Labeler DUNS
- 481233849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fa5664cc-636c-497a-80ed-3343530319f7
Device Description
Swiss LithoClast Ultra Console Upgrade Customer Owned
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
- 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 |
|---|---|---|---|---|
| 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 | 07613353116071 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012445 | 000 |