FDA UDI
In Commercial Distribution
🇺🇸 United States
LITHOCLAST
DI: 07613353151843
·
Model: B
·
E.M.S. Electro Medical Systems S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LITHOCLAST
- Primary DI
- 07613353151843
- Version / Model
- B
- Catalog Number
- FR-089#A/001
- 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
- 2021-09-07
- Public Version
- 1
- Public Version Date
- 2021-09-15
- Public Version Status
- New
- Public Device Record Key
- 5f7e95b4-9c65-4e54-b13c-8e09a7ec4299
Device Description
Pneumatic handpiece pn3 kit
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47098 | Pneumatic lithotripsy system handpiece | A hand-held component of a pneumatic intracorporeal lithotripsy system designed to hold the system's ballistic probe (i.e., it forms a handle around the probe) and is connected via a dedicated cable to the system's control unit from which energy is transmitted. The handpiece includes connectors and is typically made of metal [e.g., stainless steel, aluminium (Al)] and plastic materials. It may also facilitate suction used for the removal of the fragmented calculi. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613353151843 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963285 | 000 |