FDA UDI
In Commercial Distribution
🇺🇸 United States
mytaMed
DI: B351MVLLS4LBTP0
·
Model: mV-LLS-4LBTP
·
Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- mytaMed
- Primary DI
- B351MVLLS4LBTP0
- Version / Model
- mV-LLS-4LBTP
- Catalog Number
- mV-LLS-4LBTP
- Company Name
- Mytamed, Inc.
- Labeler DUNS
- 015903922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 3ceadb17-0189-4676-96cc-f9f6609a7573
Device Description
Rover IV Portable LED Light Source Complete with Charger and Batteries
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
- Yes
- 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
- ["High-level Disinfectant", "Hydrogen Peroxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35906 | Endoscopic light source unit, battery-powered | A battery-powered device designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B351MVLLS4LBTP0 | HIBCC |