FDA.reportPublic FDA data

FARO

Primary DI
08054320512370
Brand
FARO
Company
F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA
Model
B75
Catalog number
55U001000
Device description
B75 BP820
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
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054320512370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054320512370080543205123708054320512370

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

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
08054320512004FAROEVA5C14420012024-04-05
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
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
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