RX Locking Device and Biopsy Cap
- Primary DI
- 08714729296614
- Brand
- RX Locking Device and Biopsy Cap
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M00545260
- Device description
- Locking Device and Biopsy Cap For Use with RX Biliary System
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| ODC | Endoscope channel accessory |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729296614 | Package | GS1 | 10 | In Commercial Distribution |
| 08714729746676 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729296614 | 08714729296614 | 8714729296614 |
| 08714729746676 | 08714729746676 | 8714729746676 |
GMDN Terms
| Term | Definition |
|---|---|
| Endoscopic guidewire holder | A device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device. |
Sterilization Methods
| Method |
|---|
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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