FDA.reportPublic FDA data

ELMED

Primary DI
00842180137493
Brand
ELMED
Company
ELMED INCORPORATED
Model
98-2000
Catalog number
98-2000
Device description
ELMED LED 2000 LIGHT SOURCE W / (4) PORT LIGHT TURRET (ACMI, WOLF, STORZ, OLYMPUS)
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQHSource, Carrier, Fiberoptic Light

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180137493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180137493008421801374938421801374930842180137493

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit 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., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091896ELMED INCORPORATEDSTE12600STE126002026-07-22
00198506091902ELMED INCORPORATED37-1008137-100812026-07-22
00198506091919ELMED INCORPORATEDSTE3375906STE33759062026-07-22
00198506091926ELMED INCORPORATEDSTE241502STE2415022026-07-22
00198506091933ELMED INCORPORATED31740-2231740-222026-07-22
00198506091940ELMED INCORPORATED23-403223-40322026-07-22
00198506091957ELMED INCORPORATEDSTE5210201A4SSSTE5210201A4SS2026-07-22
00198506091964ELMED INCORPORATEDSTE321011IVSTE321011IV2026-07-22
00198506091971ELMED INCORPORATED37001-3637001-362026-07-22
00198506091988ELMED INCORPORATED24946-3424946-342026-07-22
00198506091995ELMED INCORPORATEDSTE3219400EVSTE3219400EV2026-07-22
00198506092008ELMED INCORPORATEDSTE3219401EVSTE3219401EV2026-07-22
00198506092015ELMED INCORPORATEDB9911 FAD-CB9911 FAD-C2026-07-22
00198506092053ELMED INCORPORATEDST233051ST2330512026-07-22
00198506092060ELMED INCORPORATEDST233052ST2330522026-07-22
00198506092077ELMED INCORPORATEDST233053ST2330532026-07-22
00198506092084ELMED INCORPORATEDST233054ST2330542026-07-22
00198506092091ELMED INCORPORATEDST233055ST2330552026-07-22
00198506092138ELMED INCORPORATEDST129927ST1299272026-07-22
00198506092848ELMED INCORPORATEDST5303078ST53030782026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421953MillenniumAvalign Technologies, Inc.EQH2026-07-23
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
00190776417680MillenniumAvalign Technologies, Inc.EQH2026-03-04
00198506088841ELMED INCORPORATEDELMED INCORPORATEDEQH2026-02-23
00190776415716MillenniumAvalign Technologies, Inc.EQH2026-02-04
00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
00198506086786ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086854ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
00840183530679BR Surgical, LLCBR Surgical, LLCEQH2025-09-05
00190776408534MillenniumAvalign Technologies, Inc.EQH2025-08-19
00194613020132MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00194613123154MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00190776406769MillenniumAvalign Technologies, Inc.EQH2025-07-24
00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
00190776406172MillenniumAvalign Technologies, Inc.EQH2025-07-18
00198506084089ELMED INCORPORATEDELMED INCORPORATEDEQH2025-07-17
00190776402815MillenniumAvalign Technologies, Inc.EQH2025-06-30
00198506083716ELMED INCORPORATEDELMED INCORPORATEDEQH2025-06-23
00190776401474MillenniumAvalign Technologies, Inc.EQH2025-06-10
00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03