Identity
- Trade Name
- Flex FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, reusable FDA UDI
- Device Name
- TA Drive FDA UDI
- Model / Reference
- 25463 FDA UDI
- Description
- TA Drive FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004117 FDA UDI
- 510(k) Number
- K150776 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible video otorhinolaryngoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video otorhinolaryngoscope, reusable
Flex by Medrobotics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video otorhinolaryngoscope, reusable.
- PENTAX Medical — HOYA CORPORATION · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- MEDISONO — Medisono, LLC · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- VIVIDEO — HOYA CORPORATION · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
Cleared under the same submission
K150776 also covers:
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medrobotics Corporation
Sources (1)
- FDA UDI 1f463eba-3265-43ae-8bf6-3fc88d61bc07 34 fields · synced Jun 8, 2026