FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDISONO
DI: B369MES01046
·
Model: Medisono END-VYS SV-M4K30 Rigid Endoscopy
·
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
- B369MES01046
- Version / Model
- Medisono END-VYS SV-M4K30 Rigid Endoscopy
- Catalog Number
- MES01046
- 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
- b57a8b7a-c281-4d20-bb07-c0db09a7c7cf
Device Description
Medisono END-VYS SV-M4K30 Rigid Endoscopy
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 |
|---|---|---|---|---|
| 36963 | Rigid ultrasound laparoscope | An endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics, a fibreoptic bundle, or a video system and the ultrasound probe. The probe may be built-in or inserted through a dedicated channel so that its distal tip is positioned adjacent to the targeted organ. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B369MES01046 | HIBCC |
Customer Contacts
- Phone
- 13054063931
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211882 | 000 |