| Primary Device ID | 00857599005097 |
| NIH Device Record Key | fdf09afa-0104-4434-9197-de0418bc2cf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sam coupling patch |
| Version Model Number | UB-12 |
| Company DUNS | 080128497 |
| Company Name | ZETROZ SYSTEMS, LLC |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857599005066 [Unit of Use] |
| GS1 | 00857599005080 [Package] Package: Case [4 Units] In Commercial Distribution |
| GS1 | 00857599005097 [Primary] |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-10 |
| 00857599005172 - sam(R) Advanced Gel Capture Patch | 2024-10-18 coupling patch for use with sam wearable ultrasound device |
| 00857599005165 - sam(R) Advanced Gel Capture Patch | 2024-10-18 coupling patch for use with sam wearable ultrasound device |
| 00857599005202 - sam X1 | 2022-10-07 The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries |
| 00857599005196 - sam 2.0 Long Duration Ultrasound Device for Home Use | 2021-12-08 The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal in |
| 00857599005073 - sam | 2018-07-06 wearable therapeutic ultrasound |
| 00857599005097 - sam coupling patch | 2018-07-06coupling patch for use with sam wearable ultrasound device |
| 00857599005097 - sam coupling patch | 2018-07-06 coupling patch for use with sam wearable ultrasound device |