FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CYBERWAND
DI: 00821925044173
·
Model: CW-RBPBX
·
Gyrus ACMI, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CYBERWAND
- Primary DI
- 00821925044173
- Version / Model
- CW-RBPBX
- Company Name
- Gyrus ACMI, LLC
- Labeler DUNS
- 007198742
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 4
- Public Version Date
- 2026-04-27
- Public Version Status
- Update
- Public Device Record Key
- 9f430ce6-f8a8-44b0-837b-d797167e47c2
- Distribution End Date
- 2026-04-06
Device Description
CYBERWAND PROBE SET (USL Renal/Bladder Probe) (3/PK)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 35711 | Electrohydraulic lithotripsy system | An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00821925043596 | GS1 | 3 | Not in Commercial Distribution | 2026-04-06 | |
| Primary | 00821925044173 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120303 | 000 |