FDA.reportPublic FDA data

ELMED

Primary DI
00842180160729
Brand
ELMED
Company
ELMED INCORPORATED
Model
24129-06B
Catalog number
24129-06B
Device description
TUNNELER STAINLESS STEEL BLUNT TIP 6MM
Published
2023-01-31
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180160729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180160729008421801607298421801607290842180160729

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. 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
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506095863ELMED INCORPORATEDST129100ST1291002026-10-23
00198506096310ELMED INCORPORATED12-910012-91002026-10-23
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506095863ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00198506096310ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-23
00190776435646MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435691MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435745MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436780MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776436810MillenniumAvalign Technologies, Inc.GEN2026-10-21
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01