| Primary Device ID | 00812790024940 |
| NIH Device Record Key | 1ff198f9-e26f-414b-9a3f-f5ebd4b30938 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIENTRA Vaginal Stent |
| Version Model Number | 3521-160U |
| Catalog Number | 3521-160U |
| Company DUNS | 010209877 |
| Company Name | Sientra, 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Length | 160 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812790024940 [Primary] |
| KXP | Stent, Vaginal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
| 00812790024940 | Vaginal Stent, Inflatable, 160 mm |
| 00812790024933 | Vaginal Stent, Inflatable, 140 mm |
| 00812790024926 | Vaginal Stent, Inflatable, 120 mm |
| 00812790024919 | Vaginal Stent, Inflatable, 95 mm |