FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDISONO
DI: B369MES01043
·
Model: Medisono END-VYS EG-UR5 Ultrasonic Gastrovideoscope
·
Medisono, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDISONO
- Primary DI
- B369MES01043
- Version / Model
- Medisono END-VYS EG-UR5 Ultrasonic Gastrovideoscope
- Catalog Number
- MES01043
- Company Name
- Medisono, LLC
- Labeler DUNS
- 079686615
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-17
- Public Version
- 2
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- e892738f-e821-40e8-a630-da1a23fda719
Device Description
Medisono END-VYS EG-UR5 Ultrasonic Gastrovideoscope
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17663 | Flexible video gastroscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B369MES01043 | HIBCC |
Customer Contacts
- Phone
- 13054063931
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211882 | 000 |