| Primary Device ID | B54112113130 |
| NIH Device Record Key | b9f4fae4-0e70-46da-926f-e101bae337e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Redi Splint 2 |
| Version Model Number | Redi Splint 2 |
| Catalog Number | 1211313 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B54112113130 [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 | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
| B54112113140 | Redi Splint 2, Small, Olive Drab, Folded. Moldable first aid splint. |
| B54112113130 | Redi Splint 2, Small, Olive Drab, Flat. Moldable first aid splint |