Lynx™ Blue System
- Primary DI
- 08714729961932
- Brand
- Lynx™ Blue System
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0068503010
- Device description
- Suprapubic Mid-Urethral Sling
- Published
- 2018-01-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OTN | mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729961932 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729961932 | 08714729961932 | 8714729961932 |
GMDN Terms
| Term | Definition |
|---|
| Stress urinary incontinence surgical mesh, female | A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included. |
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 00890594000155 | Desara TVez 3.0 | Caldera Medical, Inc. | OTN | 2022-08-03 |
| 00890594000193 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | OTN | 2022-08-03 |
| 00890594000087 | Desara Blue TVez 3.0 | Caldera Medical, Inc. | OTN | 2021-11-15 |
| 00890594000094 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | OTN | 2021-11-15 |
| 00890594000100 | Desara TVez 2.7 | Caldera Medical, Inc. | OTN | 2021-11-15 |
| 00890594000117 | Desara TVez 3.0 | Caldera Medical, Inc. | OTN | 2021-11-15 |
| 00191506007652 | Advantage Ultra System | BOSTON SCIENTIFIC CORPORATION | OTN | 2021-10-06 |
| 00191506007669 | Advantage Fit Ultra System | BOSTON SCIENTIFIC CORPORATION | OTN | 2021-10-06 |
| 00191506007676 | Lynx Ultra System | BOSTON SCIENTIFIC CORPORATION | OTN | 2021-10-06 |
| 00860003619803 | Athena Surgical RMUS System | Athena Surgical LLC | OTN | 2021-07-30 |
| 20860003619814 | Athena Surgical RMUS System | Athena Surgical LLC | OTN | 2021-07-30 |
| 00860003619827 | Athena Surgical RMUS System | Athena Surgical LLC | OTN | 2021-07-30 |
| 08437007606027 | Remeex System (for Female Urinary Incontinence) | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 08437007606065 | KIM (Knotless Incontinence Mesh) | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 08437007606072 | Remeex System -Readjustment kit | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 08437007606263 | Remeex System - Thread Passer | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 08437007606683 | KIM (Knotless Incontinence Mesh) | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 08437007606836 | Remeex System - Passer Handle | DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL | OTN | 2020-10-19 |
| 00890594000841 | Desara Blue TV | CALDERA MEDICAL, INC. | OTN | 2019-09-30 |
| 00890594000889 | Desara | CALDERA MEDICAL, INC. | OTN | 2019-09-30 |
| 00890594000919 | Desara TV | CALDERA MEDICAL, INC. | OTN | 2019-09-30 |
| 00860368002401 | ArcTV™ Transvaginal Sling System | UROCURE LLC | OTN | 2019-08-13 |
| 08714729961918 | Advantage™ Blue System | BOSTON SCIENTIFIC CORPORATION | OTN | 2018-01-22 |
| 08714729961925 | Advantage Fit™ Blue System | BOSTON SCIENTIFIC CORPORATION | OTN | 2018-01-22 |
| 03760151650048 | I-STOP | CL MEDICAL | OTN | 2017-05-19 |
| 03760151650055 | I-STOP | CL MEDICAL | OTN | 2017-05-19 |
| 03760151650093 | I-STOP | CL MEDICAL | OTN | 2017-05-19 |
| 03760151650185 | I-STOP | CL MEDICAL | OTN | 2017-05-19 |