FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ORISE™
DI: 08714729974628
·
Model: M00519530
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORISE™
- Primary DI
- 08714729974628
- Version / Model
- M00519530
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-05
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- bf9e5fc1-7f78-420c-8352-a0d7ccf85fc8
- Distribution End Date
- 2020-11-03
Device Description
Instrument Guide
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
| FED | endoscopic access overtube, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| ODB | endoscopic contamination prevention sheath | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62913 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729974628 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 90 deg Angle |