FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDISONO
DI: B369MES01007
·
Model: Medisono END-VYS VLS-55T Light Source
·
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
- B369MES01007
- Version / Model
- Medisono END-VYS VLS-55T Light Source
- Catalog Number
- MES01007
- 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
- 15f4f1df-5711-4ac3-8d6c-537c99406b2b
Device Description
Medisono END-VYS VLS-55T Light Source
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 |
|---|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35158 | Endoscopic light source unit, line-powered | A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B369MES01007 | HIBCC |
Customer Contacts
- Phone
- 13054063931
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211882 | 000 |