FDA UDI
In Commercial Distribution
🇺🇸 United States
VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
DI: 04961333240449
·
Model: VNL15-J10
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
- Primary DI
- 04961333240449
- Version / Model
- VNL15-J10
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b04fbaa1-170e-422b-914e-ebe01b92dcc9
Device Description
THERAPEUTIC NASOLARYNGOSCOPE (USED)
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 35462 | Flexible video laryngoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333240449 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172156 | 000 |