FDA.reportPublic FDA data

ELMED

Primary DI
00842180163546
Brand
ELMED
Company
ELMED INCORPORATED
Model
25-1011-45
Catalog number
25-1011-45
Device description
4MM, 45CM, NEW CATHETER PASSER, SHUNT GUIDE W/ HOLE IN TIP AND T-HANDLE (REUSEABLE STAINLESS STEEL)
Published
2023-04-06
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
00842180163546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180163546008421801635468421801635460842180163546

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
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
00198506039072ELMED INCORPORATEDST5240905ST52409052026-07-17
00198506092107ELMED INCORPORATEDST233061ST2330612026-07-17
00198506092114ELMED INCORPORATEDST233064ST2330642026-07-17
00198506092121ELMED INCORPORATEDST233065ST2330652026-07-17
00198506092152ELMED INCORPORATEDST1976718ST19767182026-07-17
00198506092176ELMED INCORPORATEDST5220340ST52203402026-07-17
00198506092190ELMED INCORPORATEDST5243000HST5243000H2026-07-17
00198506092206ELMED INCORPORATEDST5243004HST5243004H2026-07-17
00198506092213ELMED INCORPORATEDST5243005HST5243005H2026-07-17
00198506092220ELMED INCORPORATEDST5246000HST5246000H2026-07-17
00198506092237ELMED INCORPORATEDST5246003HST5246003H2026-07-17
00198506092244ELMED INCORPORATEDST5246004HST5246004H2026-07-17
00198506092251ELMED INCORPORATEDST5246005HST5246005H2026-07-17
00198506092268ELMED INCORPORATEDST5246006HST5246006H2026-07-17
00198506092275ELMED INCORPORATEDST5240900ST52409002026-07-17
00198506092282ELMED INCORPORATEDST5240901ST52409012026-07-17
00198506092299ELMED INCORPORATEDST5240904ST52409042026-07-17
00198506092305ELMED INCORPORATEDST5241200ST52412002026-07-17
00198506092312ELMED INCORPORATEDST5241201ST52412012026-07-17
00198506092329ELMED INCORPORATEDST5241202ST52412022026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
00842180164826ELMEDELMED INCORPORATEDPIY2023-03-10