FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506082368
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
30-411
Catalog number
30-411
Device description
Hemorrhoidal Ligator Loading Cone Tip, Pk of 5
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506082368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506082368001985060823681985060823680198506082368

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.

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
DM exempt
true
Premarket exempt
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
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
00810135963169ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963183ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963251ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962889TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962896TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
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00810135963091Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963107Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
00810135962667TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27