| Primary Device ID | B54112114000 |
| NIH Device Record Key | c598e3e1-af37-4b09-96ab-169716f69d5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wire Ladder Splint |
| Version Model Number | Wire Ladder Splint Kit |
| Catalog Number | 1211400 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B54112114000 [Primary] |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-15 |
| Device Publish Date | 2023-05-05 |
| B54112113000 | Wire Ladder splint |
| B54112114000 | 6 each wire ladder splint, 6 each gauze and 6 each safety pins. |