Primary Device ID | M732LG825D1 |
NIH Device Record Key | 18c707e5-1585-4a47-92db-5e24b3df5afb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lithoplasty® |
Version Model Number | M732LGCC825DX1 |
Catalog Number | M732LGCC825DX1 |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com | |
Phone | 1-877-775-4846 |
cs@shockwavemedical.com |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M732LG825D1 [Direct Marking] |
HIBCC | M732LGCC825DX1 [Primary] |
PPN | Percutaneous Catheter, Ultrasound |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-01-14 |
Device Publish Date | 2017-03-09 |
M732LPBC7060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC6560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC6060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC5560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC5060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC4560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC4060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LPBC3560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
M732LG825D1 | The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Conne |
M732LCC825D1 | The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lith |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LITHOPLASTY 86303120 4671165 Live/Registered |
Shockwave Medical, Inc. 2014-06-06 |