Identity
- Trade Name
- Servicable Extended FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- dental high volme evacuation valve, plastic FDA UDI
- Model / Reference
- B10116 FDA UDI
- Description
- dental high volme evacuation valve, plastic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00014081101167 FDA UDI
- FDA Product Code
- EHZ FDA UDI
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Servicable Extended by Hager Worldwide, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 79e51033-4df6-43a6-979b-114dfcac49df 35 fields · synced Jun 9, 2026