FDA.reportPublic FDA data

FARO

Primary DI
08054320512004
Brand
FARO
Company
F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA
Model
EVA
Catalog number
5C1442001
Device description
EVA BC550 BP820 THEIA PCAM TW SENS. CNUS Ceiling
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054320512004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054320512004080543205120048054320512004

GMDN Terms#

Term, Definition table
TermDefinition
Reflective dental room lightA mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428638779
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054320511960FAROEVA5S20420012024-04-05
08054320511984FAROEVA5C13420012024-04-05
08054320511991FAROEVA5C14400012024-04-05
08054320512370FAROB7555U0010002024-04-05
08034028397110FAROEDI LED5001210252023-07-07
08034028398148FAROMAIA3220104252023-07-07
08034028398162FAROMAIA3200104002023-07-07
08034028398179FAROMAIA3220104002023-07-07
08034028398216FAROMAIA3250104002023-07-07
08034028398360FAROMAIA3221104252023-07-07
08034028398377FAROMAIA3250104252023-07-07
08034028399169FAROMAIA3240293002023-07-07
08054320511106FAROMAIA3210000002023-07-07
08054320511533FAROEVA5C13600002023-07-07
08054320511601FAROEVA5S20600002023-07-07
08054320511953FAROEVA5S20400012023-07-07
08054320511977FAROEDI LED5C13400012023-07-07
08054320512158FAROEDI LED5001210252023-07-07
08054320512394FAROEDI LED5001210682023-07-07
08054320512400FAROEDI LED5001210682023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709121906MidmarkMIDMARK CORPORATIONEAZ2026-03-18
00841709121913MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121937MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121944MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121951MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121968MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121975MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121982MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121999MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122002MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122019MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122026MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122033MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122040MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122057MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122064MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122071MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122095MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122101MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122118MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122125MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122187MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122194MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122200MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122224MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122231MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122248MidmarkMIDMARK CORPORATIONEAZ2026-03-10