| Primary Device ID | 10822045428802 |
| NIH Device Record Key | 51de99d9-ac36-447f-936b-1b71805a0a5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAM Soft Shell Splint |
| Version Model Number | SS544-EN |
| Company DUNS | 131084188 |
| Company Name | SAM Medical Products |
| 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 | false |
| 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 | true |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com | |
| Phone | 5036395474 |
| raqa@sammedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00822045428805 [Primary] |
| GS1 | 10822045428802 [Package] Contains: 00822045428805 Package: Case [20 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 | 2022-09-09 |
| Device Publish Date | 2022-09-01 |
| 10822045428864 | 9IN SOFT SHELL SPLINT |
| 10822045428833 | 12IN SOFT SHELL SPLINT |
| 10822045428802 | 15IN SOFT SHELL SPLINT |