| Primary Device ID | 00815962020030 | 
| NIH Device Record Key | ba2d7f00-9a90-4a0d-8959-4230fb82f98a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | StimRouter User Kit | 
| Version Model Number | ST2-5000 | 
| Company DUNS | 182287727 | 
| Company Name | BIONESS INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Safe | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| 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(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | |
| Phone | +1(800)211-9136 | 
| info@bioness.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815962020030 [Primary] | 
| GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2016-12-19 | 
| 00815962020030 | External Pulse Transmitter (EPT) | 
| 00815962021464 | External Electrical Field Conductor |