| Primary Device ID | 20817522010325 |
| NIH Device Record Key | 5660c44d-4b04-4729-9425-c6648bc06cfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kentec ArmBoard |
| Version Model Number | 405ABV |
| Catalog Number | 405ABV |
| Company DUNS | 066175613 |
| Company Name | KENTEC MEDICAL, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com | |
| Phone | 949-863-0810 |
| kjrooks@kentecmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817522010328 [Primary] |
| GS1 | 20817522010325 [Package] Contains: 10817522010328 Package: box [48 Units] In Commercial Distribution |
| GS1 | 30817522010322 [Package] Package: case [288 Units] In Commercial Distribution |
| 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 | 2021-12-24 |
| Device Publish Date | 2021-12-16 |
| 20817522010325 | 405 size armboard with velcro strap |
| 20817522010318 | 405 size armboard |
| 20817522010295 | 404 size armboard with velcro strap |
| 10817522010281 | 404 size armboard |
| 20817522010264 | 403 size armboard with velcro strap |
| 20817522010257 | 403 size armboard |