| Primary Device ID | 00089059400766 |
| NIH Device Record Key | 3cd586e4-d99c-4dd2-aca1-5968f672dacc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Desara SL |
| Version Model Number | CAL-DS01SL |
| Company DUNS | 130341956 |
| Company Name | CALDERA MEDICAL, 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1.866.422.5337 |
| info@calderamedical.com |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00089059400766 [Primary] |
| GS1 | 00890594000742 [Package] Package: box [5 Units] In Commercial Distribution |
| GS1 | 00890594000759 [Package] Package: box [1 Units] In Commercial Distribution |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-05-27 |
| 00089059400766 | Desara® SL sling system for female stress urinary incontinence. |
| 00890594000766 | Desara® SL sling system for female stress urinary incontinence. |