FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919933373
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5029550U0
Device description
BEAM CORDLESS HEADLIGHT SYSTEM
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919933373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919933373008879199333738879199333730887919933373

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, battery-poweredA battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
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08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024340Axiom BladesBRAXM-HP8SBRAXM-HP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29

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