| Primary Device ID | 08806133010136 |
| NIH Device Record Key | d6fb318f-f8ac-4cd9-905e-f3a300bda365 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALFIS-3 |
| Version Model Number | FPRR028 |
| Catalog Number | FPRR028 |
| Company DUNS | 689062203 |
| Company Name | Boditech Med Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806133010136 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-14 |
| Device Publish Date | 2021-12-06 |
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