TACTRA
- Primary DI
- 08714729979340
- Brand
- TACTRA
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- 720080-01
- Catalog number
- 720080-01
- Device description
- Malleable Penile Prosthesis
- Published
- 2019-05-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FAE | PROSTHESIS, PENILE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FAE | Prosthesis, Penile | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729979340 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729979340 | 08714729979340 | 8714729979340 |
GMDN Terms
| Term | Definition |
|---|
| Rigid penile prosthesis | A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850299008443 | RIGI10 | Rigicon, Inc. | FAE | 2024-01-26 |
| 00850299008450 | RIGI10 | Rigicon, Inc. | FAE | 2024-01-26 |
| 00850299008467 | RIGI10 | Rigicon, Inc. | FAE | 2024-01-26 |
| 00850299008474 | RIGI10 | Rigicon, Inc. | FAE | 2024-01-26 |
| 00850299008481 | RIGI10 | Rigicon, Inc. | FAE | 2024-01-26 |
| 00850299008009 | RIGI10™ | RIGICON, INC. | FAE | 2019-12-12 |
| 00850299008016 | RIGI10™ | RIGICON, INC. | FAE | 2019-12-12 |
| 00850299008023 | RIGI10™ | RIGICON, INC. | FAE | 2019-12-12 |
| 00850299008030 | RIGI10™ | RIGICON, INC. | FAE | 2019-12-12 |
| 00850299008047 | RIGI10™ | RIGICON, INC. | FAE | 2019-12-12 |
| 08714729979357 | TACTRA | BOSTON SCIENTIFIC CORPORATION | FAE | 2019-05-06 |
| 08714729979364 | TACTRA | BOSTON SCIENTIFIC CORPORATION | FAE | 2019-05-06 |
| 00878953000497 | Sizer | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-09-24 |
| 00878953000503 | Sizer | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-09-24 |
| 00878953005201 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005218 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005225 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005232 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005249 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005256 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005270 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005287 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005294 | Spectra | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005393 | Spectra RTE Kit | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 00878953005409 | Spectra RTE Kit | AMERICAN MEDICAL SYSTEMS, INC. | FAE | 2016-08-12 |
| 05708932324687 | Genesis | Coloplast A/S | FAE | 2015-10-28 |
| 05708932324748 | Genesis | Coloplast A/S | FAE | 2015-10-28 |
| 05708932324809 | Genesis | Coloplast A/S | FAE | 2015-10-28 |