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Focu-Tip No.9.5 (set/2) White Light Intensifying Tip
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP FDA UDI
- Generic Name
- LED dental light, battery-powered FDA UDI
- Device Name
- FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP FDA UDI
- Model / Reference
- 355086 FDA UDI
- Description
- FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- D2483550861 FDA UDI
- FDA Product Code
- EAY FDA UDI
- GMDN Term
- LED dental light, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4620 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: LED dental light, battery-powered
Focu-Tip No.9.5 (set/2) White Light Intensifying Tip by Hager Worldwide, 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
- Hager Worldwide, Inc.
Sources (1)
- FDA UDI de8ea2e3-12e1-420f-9bc9-d8fb6a4734a4 34 fields · synced Jun 9, 2026