Lithoplasty® M732LGCC825DX1
GUDID M732LG825D1
The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Connector Cable to the Lithoplasty® Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M732LG825D1 [Direct Marking] |
| HIBCC | M732LGCC825DX1 [Primary] |
FDA Product Code
| PPN | Percutaneous Catheter, Ultrasound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-14 |
| Device Publish Date | 2017-03-09 |
On-Brand Devices [Lithoplasty®]
| 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 |
Trademark Results [Lithoplasty]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LITHOPLASTY 86303120 4671165 Live/Registered |
Shockwave Medical, Inc. 2014-06-06 |
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