FDA.reportPublic FDA data

Enova Illumination

Primary DI
00850025993265
Brand
Enova Illumination
Company
Enova Illumination, Inc.
Model
99999-002
Catalog number
99999-002
Device description
Surgical Loupes
Published
2021-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850025993265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025993265008500259932658500259932650850025993265

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

Contacts#

Phone, Email table
PhoneEmail
13135597444jward@goenova.com

Regulatory Flags#

DUNS number
080805136
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810186670238Enova Illumination90096-XX12026-04-08
00810186670245Enova Illumination90094-0012026-04-08
00810186670252Enova Illumination90094-0032026-04-08
00810186670269Enova Illumination90095-0012026-04-08
00810186670276Enova Illumination90095-0032026-04-08
00810186670283Enova Illumination90092-0012026-04-08
00810186670290Enova Illumination90092-0022026-04-08
00810186670306Enova Illumination90092-0032026-04-08
00810186670313Enova Illumination90092-0042026-04-08
00810186670320Enova Illumination90093-0012026-04-08
00810186670337Enova Illumination90093-0022026-04-08
00810186670344Enova Illumination90093-0032026-04-08
00810186670351Enova Illumination90093-0042026-04-08
00810186670368Enova Illumination90097-0012026-04-08
00810186670375Enova Illumination90097-0022026-04-08
00810186670382Enova Illumination90097-0032026-04-08
00810186670399Enova Illumination90097-0042026-04-08
00810186670221Enova Illumination90096-XX32026-03-31
00810186670214Enova Illumination80150-00C2026-02-27
00810186670146Enova Illumination80801-0012025-12-10

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