FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WI-FI DERMATOSCOPE TRIPLE WHITE/UV/POLARIZED LIGHTING
DI: B1621061
·
Model: BTS-106
·
BELLEGROVE MEDICAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WI-FI DERMATOSCOPE TRIPLE WHITE/UV/POLARIZED LIGHTING
- Primary DI
- B1621061
- Version / Model
- BTS-106
- Company Name
- BELLEGROVE MEDICAL SUPPLY, INC.
- Labeler DUNS
- 141647094
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-18
- Public Version
- 2
- Public Version Date
- 2022-08-31
- Public Version Status
- Update
- Public Device Record Key
- adb1ad5a-f32f-4fd4-b86d-9879e8c81470
- Distribution End Date
- 2022-08-31
Device Description
FedMedMicFiUVWP, with white light, UV light and polarizing filter, is a digital dermatoscope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1621061 | HIBCC |