| Primary Device ID | B54111265220 |
| NIH Device Record Key | fb379dbf-9679-40eb-b5aa-bab300e0c4bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QD-3 Traction Splint |
| Version Model Number | Pediatric/aluminum |
| Catalog Number | 1126522 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B54111265220 [Primary] |
| HSP | Splint, Traction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
| B54111265220 | QD-3 Leg traction splint with aluminum ratchet, Pediatric |
| B54111265120 | QD-3 Leg traction splint, with molded ratchet, Pediatric |