FDA UDI
In Commercial Distribution
🇺🇸 United States
LITHOCLAST
DI: 07613353311582
·
Model: FT-235US-MAX
·
E.M.S. Electro Medical Systems S.A.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- LITHOCLAST
- Primary DI
- 07613353311582
- Version / Model
- FT-235US-MAX
- Catalog Number
- M006840202K0
- 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
- 2024-03-20
- Public Version
- 2
- Public Version Date
- 2024-05-15
- Public Version Status
- Update
- Public Device Record Key
- 7af440a3-6968-4246-859c-da6b75a71b00
Device Description
Swiss LithoClast Trilogy Max System Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 65258 | Electromechanical/ultrasonic lithotripsy system | An assembly of electrically-powered devices designed to generate both: 1) electromechanically-created ballistic shock waves; and 2) ultrasonic waves (used in combination or individually) for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a power regulator/control unit and handpiece. A probe is attached to the handpiece connected to the control unit that supplies the energy for both the electromechanical and ultrasonic functions. The fragmented calculi are removed by suction typically produced by an incorporated suction pump. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07613353176686 | GS1 | ||||
| Primary | 07613353311582 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173234 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius