Primary Device ID | 00195451000355 |
NIH Device Record Key | 5c297e9e-f83c-49d1-b1a4-44d5e4939e82 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable |
Version Model Number | 825Dx |
Catalog Number | IVLGCCDX |
Company DUNS | 055514478 |
Company Name | Shockwave Medical, 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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |