Identity
- Trade Name
- MICROPHONE ASSAY KIT FDA UDI
- Generic Name
- Speech assistive training device FDA UDI
- Device Name
- 6651 MICROPHONE ASSAY KIT(MU0P00001022)(Accessory for PAS 6600) FDA UDI
- Model / Reference
- 6651 FDA UDI
- Description
- 6651 MICROPHONE ASSAY KIT(MU0P00001022)(Accessory for PAS 6600) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333255979 FDA UDI
- FDA Product Code
- KLX FDA UDI
- GMDN Term
- Speech assistive training device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1325 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Speech assistive training device
Microphone Assay Kit by PENTAX of America, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 88f73aa5-a56a-4526-b2ec-2c6556ba5c17 33 fields · synced May 30, 2026