CARDINAL HEALTH
- Primary DI
- 50197106676965
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- SOT29APAMA
- Catalog number
- SOT29APAMA
- Device description
- AMC PENILE PROSTHESIS PACK
- Published
- 2024-07-09
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50197106676965 | Package | GS1 | 2 | In Commercial Distribution |
| 10197106676967 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 50197106676965 | 50197106676965 |
| 10197106676967 | 10197106676967 |
GMDN Terms
| Term | Definition |
|---|
| Urological surgical procedure kit, medicated, single-use | A collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. 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
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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