| Primary Device ID | B5411211308 |
| NIH Device Record Key | 0cbdec93-1b28-4f9a-9d2f-2aaeb167aa15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Redi Splint |
| Version Model Number | Redi Splint |
| Catalog Number | 1211308 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B5411211308 [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 | 2021-05-10 |
| Device Publish Date | 2021-05-01 |
| B54112113510 | Redi Splint, Extra Small, black, 3"x14", flat |
| B54112113500 | Redi Universal Splint, black, folded, 3.5x18 |
| B54112113390 | Redi Universal Splint, large, olive drab, rolled |
| B54112113380 | Redi Universal Splint, Large, black, rolled |
| B54112113320 | Redi Universal Splint, Olive Drab, 4"x18" |
| B54112113290 | Redi Universal Splint, Large, Olive Drab, Folded. Moldable first aid splint. |
| B54112113280 | Redi Universal Splint, Large, Black, Folded. Moldable first aid splint. |
| B54112113220 | Redi Universal Splint, Small, Olive Drab, Folded. Moldable first aid splint. |
| B54112113210 | Redi Universal Splint, Small, Olive Drab, Flat. Moldable first aid splint. |
| B54112113200 | Redi Universal Splint, Small, Black, Folded. Moldable first aid splint. |
| B54112113190 | Redi Universal Splint, Small, Black, Flat. Moldable first aid splint. |
| B5411211318F0 | Redi Splint, Large, Black, Fieldtex. Moldable first aid splint |
| B54112113180 | Redi Splint, Large, Black, Folded. Moldable first aid splint |
| B54112113160 | Redi Splint 2, Small, Black, Folded. Moldable first aid splint |
| B54112113150 | Redi Universal Splint, extra small, black, folded. Moldable first aid splint. |
| B54112113120 | Redi Splint, Large, Olive Drab, Folded. Moldable first aid splint |
| B54112113100 | Redi Splint, Large, Olive Drab, flat. Moldable first aid splint. |
| B54112113090 | Redi Splint, Large, black, flat. Moldable first aid splint |
| B54112113060 | Redi Splint, Small, black, Flat. Moldable first aid splint |
| B54112113050 | Redi Universal splint, extra small , black, flat. Moldable first aid splint |
| B5411211308 | Redi Splint, Large, Black, Box of 4 |
| B5411211307 | Redi Splint 2, Small, Black, Box of 4 |
| B54112113081 | Redi Splint, Large, Black, Box of 4 |
| B54112113071 | Redi Splint 2, Small, Black, Box of 4 |