Olympus
GUDID 00821925043817
LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm
Gyrus Acmi, Inc.
Ultrasonic lithotripsy system probe, reusable| Primary Device ID | 00821925043817 |
| NIH Device Record Key | 6c570eb3-2710-4a89-b462-23a376b42283 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Olympus |
| Version Model Number | SPL-PR376 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925043817 [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 |
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
[00821925043817]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-31 |
| Device Publish Date | 2024-07-23 |
On-Brand Devices [Olympus]
| 00821925043060 | SINGLE USE ASPIRATION NEEDLE |
| 00821925042506 | SINGLE USE ASPIRATION NEEDLE |
| 00821925007802 | M3 Gold Autoclavable Foroblique Telescope 30°, Color Coded White |
| 00821925035836 | HIGH SPEED DRILL TUBESET, STANDARD |
| 00821925035805 | High Speed Drill, Irrigation Clip |
| 00821925035652 | HIGH SPEED MULTI DRILL STAPES ATTACHMENT |
| 00821925035645 | HIGH SPEED MULTI DRILL ANGLED LONG ATTACHMENT |
| 00821925035638 | HIGH SPEED MULTI DRILL STRAIGHT LONG ATTACHMENT |
| 00821925035621 | HIGH SPEED MULTI DRILL ANGLED SHORT ATTACHMENT |
| 00821925035614 | HIGH SPEED MULTI DRILL STRAIGHT SHORT ATTACHMENT |
| 00821925035607 | High Speed Multi Drill Hand Piece / Otology |
| 00821925044524 | POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION |
| 00821925044562 | POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION |
| 00821925044548 | POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION |
| 00821925045132 | POWERSEAL 5 MM, 44 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK) |
| 00821925043817 | LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm |
| 00821925045125 | POWERSEAL 5 MM, 37 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK) |
| 00821925045118 | POWERSEAL 5 MM, 23 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK) |
| 00821925045071 | POWERSEAL 5 MM, 44 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK) |
| 00821925045064 | POWERSEAL 5 MM, 37 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK) |
| 00821925045057 | POWERSEAL 5 MM, 23 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK) |
Trademark Results [Olympus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OLYMPUS 98323171 not registered Live/Pending |
OLYMPUS LLC 2023-12-20 |
 OLYMPUS 98183718 not registered Live/Pending |
Cable Tie Express LLC 2023-09-17 |
 OLYMPUS 98013060 not registered Live/Pending |
Olympuss Sports & Entertainment Group, LLC 2023-05-25 |
 OLYMPUS 98002376 not registered Live/Pending |
SSG International, LLC 2023-05-18 |
 OLYMPUS 97720732 not registered Live/Pending |
Valmont Industries, Inc. 2022-12-16 |
 OLYMPUS 97617017 not registered Live/Pending |
Merino, Michael 2022-10-03 |
 OLYMPUS 97493838 not registered Live/Pending |
Track Barn, LLC 2022-07-07 |
 OLYMPUS 97493792 not registered Live/Pending |
Track Barn, LLC 2022-07-07 |
 OLYMPUS 97234548 not registered Live/Pending |
Icon Technology, Inc. 2022-01-24 |
 OLYMPUS 97058514 not registered Live/Pending |
Simple Tire LLC 2021-10-04 |
 OLYMPUS 90793668 not registered Live/Pending |
Simple Tire LLC 2021-06-24 |
 OLYMPUS 90747738 not registered Live/Pending |
OLYMPUS CORPORATION 2021-06-01 |
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