FDA.reportPublic FDA data

Firefly

Primary DI
00851289007354
Brand
Firefly
Company
Firefly Global
Model
ES201M
Device description
Compact handheld light source (battery operated)
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851289007354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851289007354008512890073548512890073540851289007354

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, battery-poweredA battery-powered device designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. 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
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
00851289007187FireflyDE337T2020-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2024-06-11
06973031299894WhtNavi Light SourceGuangdong Optomedic Technologies, Inc.NTN2024-03-26