Identity
- Trade Name
- HIGH RESOLUTION DEMATOSCOPE WITH PROFESSIONAL SW FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- HIGH RESOLUTION DEMATOSCOPE WITH PROFESSIONAL SW FDA UDI
- Model / Reference
- BTS-315 FDA UDI
- Description
- HIGH RESOLUTION DEMATOSCOPE WITH PROFESSIONAL SW FDA UDI
Identifiers
- Catalog Number
- FEDMEDMICFIP6MSWD_US FDA UDI
- Primary DI / UDI-DI
- B1623151 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
High Resolution Dematoscope With Professional Sw by Bellegrove Medical Supply, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bellegrove Medical Supply, Inc.
Sources (1)
- FDA UDI 73a5c7fe-db76-4396-8930-ea7381d67933 35 fields · synced Jun 1, 2026