FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WI-FI DERMATOSCOPE POLARISED FILTER
DI: B1621021
·
Model: BTS-300
·
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 POLARISED FILTER
- Primary DI
- B1621021
- Version / Model
- BTS-300
- Catalog Number
- BTS-300
- 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
- 2022-05-02
- Public Version Status
- Update
- Public Device Record Key
- 4c323a1c-4c21-4378-b25a-b851d22625b3
- Distribution End Date
- 2022-04-30
Device Description
FedMedMicFiP, with polarised filter, is a small and portable digital dermatoscope with Wi-Fi transmission. Using proper SW and Apps you can take pictures and video using PC, smartphones or tablets.
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
- Yes
- 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 |
|---|---|---|---|---|
| 65129 | Video otoscope/audiometer | An electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch generator (speaker), and a dedicated smartphone for image display and data relay to a central datastore; it may provide a conduit for a microsuction device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1621021 | HIBCC |