Identity

Trade Name
FARO FDA UDI
Generic Name
Operating room light FDA UDI
Device Name
B75 BP820 FDA UDI
Model / Reference
B75 FDA UDI
Description
B75 BP820 FDA UDI

Identifiers

Catalog Number
55U001000 FDA UDI
Primary DI / UDI-DI
08054320512370 FDA UDI
FDA Product Code
FTD FDA UDI
GMDN Term
Operating room light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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: Operating room light

Faro by F.a.r.o. Fabbrica Apparecchiature Razionali Odontoiatriche Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b1ac9faa-693f-401a-849c-3818249182bf 34 fields · synced Jun 1, 2026