FDA.reportPublic FDA data

Enova Illumination

Primary DI
00850025993371
Brand
Enova Illumination
Company
Enova Illumination, Inc.
Model
80034-006
Device description
Enova Loupe Case
Published
2022-01-27
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
00850025993371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025993371008500259933718500259933710850025993371

GMDN Terms#

Term, Definition table
TermDefinition
Medical capital equipment storage bag/caseA non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080805136
Device count
1
DM exempt
true
Premarket exempt
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