Identity
- Trade Name
- BV Medical FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Combo Kit: Neon Green Carrying Case, 38-416-304 Sprague Rappaport-Type, Adult, Neon Green, Latex Free, Neon Green Aneroid Sphygmomanometer, Latex Free: 60-840-300-OTO Conventional 2.5V Mini Otoscope, Neon Green, Latex Free with Speculas and Carrying Case, Utility scissors 5.5": 80-170-300 stainless steel with neon green handle FDA UDI
- Model / Reference
- 20-372-304-OTO-L FDA UDI
- Description
- Combo Kit: Neon Green Carrying Case, 38-416-304 Sprague Rappaport-Type, Adult, Neon Green, Latex Free, Neon Green Aneroid Sphygmomanometer, Latex Free: 60-840-300-OTO Conventional 2.5V Mini Otoscope, Neon Green, Latex Free with Speculas and Carrying Case, Utility scissors 5.5": 80-170-300 stainless steel with neon green handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845821028976 FDA UDI
- FDA Product Code
- LRW FDA UDIERA FDA UDILDE FDA UDIDXQ FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI874.4770 FDA UDI870.1875 FDA UDI870.1120 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose surgical scissors, reusableAneroid manual sphygmomanometerMechanical external stethoscopeOtoscope, direct
BV Medical by Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medical, Inc.
Sources (1)
- FDA UDI 5c39c6a2-dde9-4cdb-9fad-710fcf2d883c 34 fields · synced Jun 8, 2026