Primary Device ID | 00821925043831 |
NIH Device Record Key | c37692e4-41e7-4f7d-96c5-86bd3e829936 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ShockPulse |
Version Model Number | SPL-T |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925043831 [Primary] |
FEO | Lithotriptor, ultrasonic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
[00821925043831]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-10 |
Device Publish Date | 2020-03-02 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SHOCKPULSE 86129743 not registered Dead/Abandoned |
OLYMPUS CORPORATION 2013-11-26 |