FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 4.5Fr (1.50mm) X 564mm
DI: 00855279005153
·
Model: SPL-PD150
·
CYBERSONICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 4.5Fr (1.50mm) X 564mm
- Primary DI
- 00855279005153
- Version / Model
- SPL-PD150
- Company Name
- CYBERSONICS INC
- Labeler DUNS
- 943561522
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-30
- Public Version
- 4
- Public Version Date
- 2021-11-30
- Public Version Status
- Update
- Public Device Record Key
- 58db95ab-9180-4de1-a00e-134024687dbe
- Distribution End Date
- 2019-12-31
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEO | Lithotriptor, Ultrasonic | Gastroenterology, Urology | 876.4480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37138 | Ultrasonic lithotripsy system handpiece | A hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855279005153 | GS1 | ||||
| Package | 10855279005150 | GS1 | 3 | Not in Commercial Distribution | 2019-12-31 |