FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919932925
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5029535U0
Device description
VE3.5TTLR-SFBLUE LOUPE REGULAR
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
FSPLOUPE, DIAGNOSTIC/SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919932925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919932925008879199329258879199329250887919932925

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. 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
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877825287EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825294EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825300EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825317EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825324EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825096EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825102EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825119EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825126EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825133EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825140EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825157EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825164EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825171EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825188EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825195EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825201EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825218EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825225EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825232EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825249EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825256EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825263EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825270EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
00850036373377Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373384Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373391Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05