FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BEAR
DI: B351MV40000
·
Model: mV-4000
·
Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BEAR
- Primary DI
- B351MV40000
- Version / Model
- mV-4000
- Catalog Number
- mV-4000
- Company Name
- Mytamed, Inc.
- Labeler DUNS
- 015903922
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-11
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- dfa68ca1-7bde-44fc-a2dc-fdde7643f0ab
- Distribution End Date
- 2020-03-11
Device Description
mView Rigid ENT Endoscope, 4.0 x 185mm, 0 Deg.
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
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Hydrogen Peroxide, Peracetic Acid, 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 |
|---|---|---|---|---|
| 37180 | Rigid optical sinoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B351MV40000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981751 | 000 |