FDA UDI
In Commercial Distribution
🇺🇸 United States
LITHOCLAST
DI: 07613353177089
·
Model: EL-419B
·
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
- 07613353177089
- Version / Model
- EL-419B
- 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
- 2019-10-07
- Public Version
- 1
- Public Version Date
- 2019-10-15
- Public Version Status
- New
- Public Device Record Key
- d1c28925-6b92-4ea5-a897-5beabbe271de
Device Description
Lateral suction connector Ø8 BSC
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 47096 | Pneumatic lithotripsy system | An assembly of devices (not all hand-held) designed to use pneumatically-created ballistic shock waves for the intracorporeal fragmentation of urinary tract calculi (stones) in the kidney, ureter, and bladder. It typically includes an electronic pressure regulator/control unit, a handpiece, probes of various sizes, and a foot-switch. A probe is attached to the handpiece which is connected to the control unit, which uses compressed air to provide the pressure pulses that propagate to the distal tip of the probe for energy transmission. Working through an appropriate endoscope, this energy is applied to a calculus for fragmentation in situ and subsequent removal using suction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613353177089 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012445 | 000 |