DEVICE: ORISE™ (08714729974635)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
ORISE™
M00519540
Not in Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
M00519540
Not in Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
Instrument Guide
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FED | endoscopic access overtube, gastroenterology-urology |
| ODB | endoscopic contamination prevention sheath |
| GAD | RETRACTOR |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 60 deg Angle |
Device Record Status
90a84031-34db-4a3d-92aa-27fde29be313
June 29, 2023
2
March 05, 2018
June 29, 2023
2
March 05, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined