SHOCKPULSE
GUDID 00821925043787
LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm
Gyrus Acmi, Inc.
Ultrasonic lithotripsy system probe, reusable| Primary Device ID | 00821925043787 |
| NIH Device Record Key | ed274852-f1dd-4cc9-a276-17299b3579f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHOCKPULSE |
| Version Model Number | SPL-PR150 |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
| Handling Environment Temperature | Between 270 Degrees Fahrenheit and 279 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 172 KiloPascal and 230 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925043787 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142428
FDA Product Code
| FEO | Lithotriptor, Ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
[00821925043787]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
On-Brand Devices [SHOCKPULSE]
| 00821925044197 | SHOCKPULSE-SE LITHOTRIPSY SYSTEM |
| 00821925043831 | SHOCKPULSE LITHOTRIPSY TRANSDUCER |
| 00821925044203 | SHOCKPULSE LITHOTRIPSY GENERATOR |
| 00821925043718 | SHOCKPULSE LITHOTRIPSY POWER CORD |
| 00821925043701 | SHOCKPULSE LITHOTRIPSY NOSE CONE |
| 00821925043695 | SHOCKPULSE LITHOTRIPSY FOOTSWITCH |
| 00821925043688 | SHOCKPULSE LITHOTRIPSY CLEANING STYLET (SMALL) |
| 00821925043671 | SHOCKPULSE LITHOTRIPSY CLEANING STYLET (LARGE) |
| 00821925043633 | CYBERWAND RENA BLADDER PROBE |
| 00821925043763 | LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm (3/Pk) |
| 00821925043756 | LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm (3/Pk) |
| 00821925043749 | LITHOTRIPSY PROBE, LITHOTRIPSY PROBE STERILE SINGLE USE, ShockPulse-SE 5.5 Fr (1.83 mm) x 418 mm |
| 00821925043732 | LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 4.5 Fr (1.50 mm) x 564 mm (3/Pk) |
| 00821925043725 | LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 2.9 Fr (0.97 mm) x 578 mm (3/Pk) |
| 00821925043824 | LITHOTRIPSY SYSTEM SHOCKPULSE-SE |
| 00821925043800 | LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm |
| 00821925043794 | LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 5.5 Fr (1.83 mm) x 418 mm |
| 00821925043787 | LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm |
Trademark Results [SHOCKPULSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHOCKPULSE 86129743 not registered Dead/Abandoned |
OLYMPUS CORPORATION 2013-11-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.