ORISE™
- Primary DI
- 08714729974611
- Brand
- ORISE™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M00519520
- Device description
- Instrument Guide
- Published
- 2018-03-05
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GAD | Retractor | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729974611 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729974611 | 08714729974611 | 8714729974611 |
GMDN Terms
| Term | Definition |
|---|
| Multichannel gastrointestinal endoscopic guide, non-steerable | A non-sterile, non-steerable, multi-luminal, flexible tube intended to function as a housing for a compatible flexible endoscope and endoscopic tool(s), to facilitate introduction of the endoscope, and provide independent working channels/insufflation ports (i.e., not through the endoscope) during endoscopic procedures of the gastrointestinal (GI) tract. It includes proximal ports, a flexible shaft, and includes a retracting mechanism to provide a stable endoluminal working space. It may assist in the repeated advancement and withdrawal of the endoscope or endoscopic devices. This is a single-use device. |
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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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