FDA.reportPublic FDA data

Firefly

Primary DI
00851289007088
Brand
Firefly
Company
Firefly Global
Model
DE400
Device description
Digital Iris Scope
Published
2018-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRBMicroscope, Operating, Non-Electric, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRBMicroscope, Operating, Non-Electric, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851289007088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851289007088008512890070888512890070880851289007088

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical camera lens, extraocularA non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the surface of the eye and adjacent areas. It may use white and/or blue light for the capture of specialized images (e.g., dry eye). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020089936
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851289007347FireflyDE6082025-07-18
00851289007354FireflyES201M2025-07-18
00851289007309FireflyDE3082024-10-24
00851289007316FireflyDE334T2024-10-24
00851289007323FireflyDE4082024-10-24
00851289007330Firefly DE5082024-10-24
00851289007293FireflyES6152024-07-01
00851289007286Firefly GlobalES1202023-10-16
00851289007279FireflyES10342023-10-13
00851289007231Firefly GlobalES10402022-12-06
00851289007224Firefly DE12702022-09-20
00851289007217Firefly GlobalES20402022-08-31
00851289007002FireflyES2012016-09-24
00851289007101Firefly DE5702020-02-13
00851289007125Firefly ES1002020-02-13
00851289007132Firefly ES1032020-02-13
00851289007149Firefly ES1042020-02-13
00851289007156FireflyES1052020-02-13
00851289007163FireflyES1502020-02-13
00851289007170Firefly ES1602020-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770520244Bausch + LombBausch & Lomb IncorporatedHRB2025-08-08
00851289007323FireflyFirefly GlobalHRB2024-10-24