FDA.reportPublic FDA data

ELMED

Primary DI
00842180197732
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST23GPSMC
Catalog number
ST23GPSMC
Device description
GRAFT PUSHER; WODEN HANDLE, S/S SHAFT, 265MM OAL, 145MM W/L, 7MM FLARED TIP
Published
2024-04-18
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
PIYStainless Steel Instrument, Shunt System Implantation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIYStainless Steel Instrument, Shunt System ImplantationNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180197732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180197732008421801977328421801977320842180197732

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506044366ELMEDST52732404EST52732404E2026-06-09
00198506091278ELMED INCORPORATED55013-10A55013-10A2026-06-09
00198506091285ELMED INCORPORATED12-53785-042T12-53785-042T2026-06-09
00198506091292ELMED INCORPORATEDSS22-5200-09ASS22-5200-09A2026-06-09
00198506091308ELMED INCORPORATEDSS22-5200-09FSS22-5200-09F2026-06-09
00198506091315ELMED INCORPORATEDSTE379670STE3796702026-06-09
00198506091322ELMED INCORPORATEDSTE379675STE3796752026-06-09
00198506091339ELMED INCORPORATEDSTESM150526JC08ISTESM150526JC08I2026-06-09
00198506091346ELMED INCORPORATEDSTE4570910STE45709102026-06-09
00198506091353ELMED INCORPORATEDSTE239935STE2399352026-06-09
00198506091360ELMED INCORPORATED37350-64C137350-64C12026-06-09
00198506091377ELMED INCORPORATEDS37520-64C1S37520-64C12026-06-09
00198506091384ELMED INCORPORATED37520-06C137520-06C12026-06-09
00198506091391ELMED INCORPORATEDS37520-06C1S37520-06C12026-06-09
00198506091407ELMED INCORPORATEDSTE122857STE1228572026-06-09
00198506091476ELMED INCORPORATED12-36-1812-36-182026-06-09
00198506091483ELMED INCORPORATED51-4080-0851-4080-082026-06-09
00198506091490ELMED INCORPORATEDSTE321202EVSTE321202EV2026-06-09
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090875ELMED INCORPORATEDELMED INCORPORATEDPIY2026-05-18
00190776421007MillenniumAvalign Technologies, Inc.PIY2026-04-30
00190776410841MillenniumAvalign Technologies, Inc.PIY2025-09-12
00190776410858MillenniumAvalign Technologies, Inc.PIY2025-09-12
00198506085062ELMED INCORPORATEDELMED INCORPORATEDPIY2025-09-05
00190776401900MillenniumAvalign Technologies, Inc.PIY2025-06-16
00198506082917ELMED INCORPORATEDELMED INCORPORATEDPIY2025-05-22
00190776395957MillenniumAvalign Technologies, Inc.PIY2025-05-09
00198506082511ELMED INCORPORATEDELMED INCORPORATEDPIY2025-04-30
00198506081958ELMED INCORPORATEDELMED INCORPORATEDPIY2025-04-07
00198506075469ELMED INCORPORATEDELMED INCORPORATEDPIY2025-02-20
00190776389215MillenniumAvalign Technologies, Inc.PIY2024-11-15
00198506061325ELMED INCORPORATEDELMED INCORPORATEDPIY2024-09-11
00198506061110ELMED INCORPORATEDELMED INCORPORATEDPIY2024-09-05
00842180199408ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199415ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199422ELMEDELMED INCORPORATEDPIY2024-04-23
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00842180192096ELMEDELMED INCORPORATEDPIY2024-04-16
00842180192102ELMEDELMED INCORPORATEDPIY2024-04-16
00842180187382ELMEDELMED INCORPORATEDPIY2024-03-06
00190776299484MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776300630MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776301088MillenniumAvalign Technologies, Inc.PIY2023-11-15
00190776376123MillenniumAvalign Technologies, Inc.PIY2023-09-08
00842180175624ELMEDELMED INCORPORATEDPIY2023-08-08
00842180175631ELMEDELMED INCORPORATEDPIY2023-08-08
00842180163546ELMEDELMED INCORPORATEDPIY2023-04-06
00842180164826ELMEDELMED INCORPORATEDPIY2023-03-10