FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVIDEO
DI: 04961333255306
·
Model: VNL9-CP
·
HOYA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VIVIDEO
- Primary DI
- 04961333255306
- Version / Model
- VNL9-CP
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-19
- Public Version
- 1
- Public Version Date
- 2025-12-29
- Public Version Status
- New
- Public Device Record Key
- 73aa8b4b-21db-407d-a258-6fb5a27dd2de
Device Description
VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP (ORDER CODE: 91042)
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- Sterilization Methods
- Liquid Chemical, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45067 | Flexible video otorhinolaryngoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04961333255245 | GS1 | ||||
| Primary | 04961333255306 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171011 | 000 |