FDA UDI
In Commercial Distribution
🇺🇸 United States
LITHOCLAST
DI: 07613353312046
·
Model: FR-362R
·
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
- LITHOCLAST
- Primary DI
- 07613353312046
- Version / Model
- FR-362R
- Catalog Number
- M006840215R0
- 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
- 2024-07-17
- Public Version Status
- Update
- Public Device Record Key
- a0b88fa7-d0a2-41f9-8c08-a3529ff0859d
Device Description
Swiss LithoClast Trilogy Wireless Foot Switch-Repaired
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 |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613353312046 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230893 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal