| Primary Device ID | B54180030080 |
| NIH Device Record Key | 388fc2cc-9aa0-4ac5-ab8c-0df0979eb97e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pelvic Binder |
| Version Model Number | Pelvic Binder, Coyote Brown |
| Catalog Number | 8003008 |
| Company DUNS | 626802540 |
| Company Name | FARETEC, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com | |
| Phone | 440-350-9510 |
| colleen@faretec.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B54180030080 [Primary] |
| IPW | Orthosis, Sacroiliac, Soft |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-07 |
| Device Publish Date | 2024-02-28 |
| B54180030070 | Pelvic Binder, EMS Red, with traction attachment |
| B54180030060 | Pelvic Binder, EMS Red |
| B54180030040 | Pelvic Binder, EMS, Blue |
| B54180030030 | Pelvic Binder, Tactical, black with traction attachment |
| B54180030020 | Pelvic Binder, Tactical, black |
| B54180030010 | Pelvic Binder, Military, Camo with traction attachment |
| B54180030000 | Pelvic Binder, Military, camo |
| B54180030050 | Pelvic Binder, EMS, Blue with traction attachment |
| B54180030080 | Pelvic binder, coyote brown |