CARDINAL HEALTH
- Primary DI
- 50198956292015
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- SOT54PIUAA
- Catalog number
- SOT54PIUAA
- Device description
- PENILE IMPLANT PACK
- Published
- 2026-01-22
- Public version status
- New
- 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 |
|---|
| QGA | Penile implant surgical accessories |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QGA | Penile Implant Surgical Accessories | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50198956292015 | Package | GS1 | 3 | In Commercial Distribution |
| 10198956292017 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 50198956292015 | 50198956292015 |
| 10198956292017 | 10198956292017 |
GMDN Terms
| Term | Definition |
|---|
| Urological surgical procedure kit, non-medicated, single-use | A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- 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 |
|---|
| 50198956340518 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2026-03-23 |
| 50198956289718 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2026-03-19 |
| 50198956101607 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2026-01-26 |
| 50198956252927 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-12-10 |
| 50198956265187 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-11-17 |
| 50198956136289 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-08-22 |
| 50198956165371 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-08-11 |
| 50198956167191 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-08-11 |
| 50198956128680 | CARDINAL HEALTH | Cardinal Health 200, LLC | QGA | 2025-07-29 |
| 00850033207811 | RIGICON DILATOM™ | Rigicon, Inc. | QGA | 2024-06-26 |
| 00850033207828 | RIGICON DILATOM™ | Rigicon, Inc. | QGA | 2024-06-26 |
| 00850033207842 | RIGICON DILATOM™ | Rigicon, Inc. | QGA | 2024-06-26 |
| 00850033207873 | RIGICON DILATOM™ | Rigicon, Inc. | QGA | 2024-06-26 |
| 00850033207880 | RIGICON DILATOM™ | Rigicon, Inc. | QGA | 2024-06-26 |
| 00191506022181 | Furlow | BOSTON SCIENTIFIC CORPORATION | QGA | 2022-11-18 |
| 00878953005386 | Sizer | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2017-03-31 |
| 00878953000176 | Furlow Insertion Tool | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-25 |
| 00878953005379 | Disposable Dilators | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-25 |
| 00878953000558 | Insertion Package | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-24 |
| 00878953000664 | Deactivation Package | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-24 |
| 00878953000701 | Closing Tool | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-24 |
| 00878953000831 | Quick Connect Assembly Tool | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-24 |
| 00878953005355 | Disposable Dilators | AMERICAN MEDICAL SYSTEMS, INC. | QGA | 2014-09-24 |