NA
- Primary DI
- 08714729005452
- Brand
- NA
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0062601030
- Device description
- Amplatz Type Renal Dilator
- Published
- 2016-09-24
- 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 |
|---|
| GCC | Dilator, catheter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GCC | Dilator, Catheter | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729005452 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729005452 | 08714729005452 | 8714729005452 |
GMDN Terms
| Term | Definition |
|---|
| Multi-purpose percutaneous drainage catheter | A sterile flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. It may include disposable devices dedicated to catheter introduction. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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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| G586UR96282230 | Novo Surgical | NOVO SURGICAL, INC. | GCC | 2023-12-18 |
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| G586UR96282310 | Novo Surgical | NOVO SURGICAL, INC. | GCC | 2023-12-18 |
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| 00842962125557 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-29 |
| 00842962125564 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-29 |
| 00842962124345 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |
| 00842962124352 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |
| 00842962124369 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |
| 00842962124376 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |
| 00842962124383 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |
| 00842962124390 | HNM MEDICAL | HNM STAINLESS, LLC. | GCC | 2023-03-23 |