| Primary Device ID | 00859718007265 |
| NIH Device Record Key | 5bdbf693-36b7-4d88-9cd0-4dfe7f06500c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-Fit Back Brace |
| Version Model Number | FLEBB0003 - Back |
| Company DUNS | 932471881 |
| Company Name | Emsi |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859718007265 [Primary] |
| IPY | Orthosis, Lumbo-Sacral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-29 |
| Device Publish Date | 2023-03-21 |
| 00858688006964 - Electrode 45 x 45 16 PK | 2023-09-28 |
| 00858688006971 - Electrode 1.75 x 1.75 4 pack | 2023-09-28 |
| 00859718007074 - Electrode 1.75 x 1.75 - 24 PK | 2023-09-28 |
| 00859718007081 - Electrode 4.0 x 7.0- Dispersive | 2023-09-28 |
| 00859718007098 - Electrode 1 Inch Round 4 PK | 2023-09-28 |
| 00859718007104 - Electrode 2" round 4pk | 2023-09-28 |
| 00859718007111 - Electrode 3 Inch Round 4PK | 2023-09-28 |
| 00859718007135 - Electrode 2 x 4 Inch Rectangle | 2023-09-28 |