Identity
- Trade Name
- ENT Pocket Light FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- ENT Pocket Light - Basic Set Otoscope set with disposable specula and nasal head. FDA UDI
- Model / Reference
- PL2 Blue FDA UDI
- Description
- ENT Pocket Light - Basic Set Otoscope set with disposable specula and nasal head. FDA UDI
Identifiers
- Catalog Number
- ENT-PL2-BL FDA UDI
- Primary DI / UDI-DI
- 00850013958016 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
- 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ear speculum, reusableOtoscope, directEar speculum, single-useENT diagnostic set
ENT Pocket Light by C F M Technologies 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
- C F M Technologies Inc
Sources (1)
- FDA UDI 46fe99a4-2409-4680-9745-bbd8a0b87e9d 35 fields · synced Jun 1, 2026