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| 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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