CYBERWAND
GUDID 00821925043596
CYBERWAND PROBE SET (USL Renal / Bladder Probe)
Gyrus Acmi, Inc.
Electrohydraulic lithotripsy system| Primary Device ID | 00821925043596 |
| NIH Device Record Key | 9f430ce6-f8a8-44b0-837b-d797167e47c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CYBERWAND |
| Version Model Number | CW-RBPBX |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925043596 [Package] Contains: 00821925044173 Package: [3 Units] In Commercial Distribution |
| GS1 | 00821925044173 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120303
FDA Product Code
| FFK | Lithotriptor, Electro-Hydraulic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2024-07-25 |
Devices Manufactured by Gyrus Acmi, Inc.
| 00821925043916 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron |
| 00821925043930 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043978 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron |
| 00821925043992 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron |
| 00821925044074 - SOLTIVE | 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron |
| 00821925002074 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002098 - USA Elite System | 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow |
| 00821925002111 - USA Elite System | 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold |
Trademark Results [CYBERWAND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYBERWAND 77090051 3416860 Live/Registered |
Cybersonics, Inc. 2007-01-24 |
 CYBERWAND 76248555 not registered Dead/Abandoned |
Cyberonics, Inc. 2001-05-01 |
 CYBERWAND 75751066 not registered Dead/Abandoned |
Cybersonics, Inc 1999-07-06 |
 CYBERWAND 75095844 not registered Dead/Abandoned |
Cybersonics, Inc. 1996-04-29 |
 CYBERWAND 74521878 1951908 Dead/Cancelled |
INWORLD VR, INC. 1994-05-03 |
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