| Primary Device ID | 00048503513283 |
| NIH Device Record Key | b91ed638-3ebc-43a7-ac25-0a55f6e7598d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Truform® |
| Version Model Number | 18868BG-L |
| Company DUNS | 004247383 |
| Company Name | SURGICAL APPLIANCE INDUSTRIES, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00048503513283 [Primary] |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-25 |
| Device Publish Date | 2025-04-17 |