| Primary Device ID | 00812265010201 |
| NIH Device Record Key | 5e388be3-4a58-4053-a21c-cda42c1c704e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dermaPACE Applicator |
| Version Model Number | DAP0332 |
| Company DUNS | 832217439 |
| Company Name | Sanuwave, 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 | false |
| OTC Over-The-Counter | false |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com | |
| Phone | 678-578-0108 |
| order@sanuwave.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812265010201 [Primary] |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-02 |
| Device Publish Date | 2021-01-25 |
| 00812265010201 - dermaPACE Applicator | 2021-02-02Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers |
| 00812265010201 - dermaPACE Applicator | 2021-02-02 Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers |
| 00812265010218 - dermaPACE Console | 2021-02-02 Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock W |
| 00812265010225 - dermaPACE System (Console with applicator) | 2021-02-02 The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generat |
| 00812265010287 - Profile Console | 2021-02-02 Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic |
| 00812265010294 - Profile Applicator | 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100) |
| 00812265010300 - Profile Applicator | 2021-02-02 Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100) |
| 00812265010317 - UltraMIST Generator | 2021-02-02 The UltraMIST Generator |
| 00812265010324 - UltraMIST Treatment Wand | 2021-02-02 Component to the UltraMIST System |