Identity
- Trade Name
- HOSE ISOLITE/MC2 WHITE FDA UDI
- Generic Name
- Pneumatic dental power tool hose FDA UDI
- Device Name
- Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI
- Model / Reference
- 1600314-001 FDA UDI
- Description
- Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI
Identifiers
- Catalog Number
- 1600314-001 FDA UDI
- Primary DI / UDI-DI
- J00716003140011 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental power tool hose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumatic dental power tool hose
Hose Isolite/Mc2 White by Bien-Air Portugal, Unipessoal, Lda — 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
- Bien-Air Portugal, Unipessoal, Lda
Sources (1)
- FDA UDI 478e234b-866f-4af2-abe4-32dffb2c0646 35 fields · synced May 30, 2026