| Primary Device ID | 00191506007669 |
| NIH Device Record Key | c6b98e3c-520f-48d9-bd37-fd1a64f2d669 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advantage Fit Ultra System |
| Version Model Number | M0068502160 |
| Catalog Number | M0068502160 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506007669 [Primary] |
| OTN | mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-14 |
| Device Publish Date | 2021-10-06 |
| 00802526618208 - myLUX™ Patient App | 2025-04-21 For Insertable Cardiac Monitor |
| 00802526618215 - myLUX™ Patient App | 2025-04-21 for Insertable Cardiac Monitor |
| 00191506046330 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046347 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046354 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046361 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046378 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |
| 00191506046385 - Sterling™ | 2025-03-31 PTA Balloon Dilatation Catheter |