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
00198506091155ELMED INCORPORATED37-5006-10ST37-5006-10ST2026-06-03
00198506091162ELMED INCORPORATED37-1010137-101012026-06-03
00198506091179ELMED INCORPORATEDSTE287850STE2878502026-06-03
00198506091186ELMED INCORPORATED37-013837-01382026-06-03
00198506091193ELMED INCORPORATED37-013937-01392026-06-03
00198506091209ELMED INCORPORATEDSTE1121040STE11210402026-06-03
00198506091216ELMED INCORPORATEDSTE3321924STE33219242026-06-03
00198506091223ELMED INCORPORATED42-242042-24202026-06-03
00198506091230ELMED INCORPORATEDSM13443-21-CRSM13443-21-CR2026-06-03
00198506091247ELMED INCORPORATED52125-7952125-792026-06-03
00198506091254ELMED INCORPORATED52105-61-0552105-61-052026-06-03
00198506091261ELMED INCORPORATED5990M255990M252026-06-03
00842180192515ELMEDST180831ST1808312024-04-10
00842180167766ELMED18-083118-08312023-04-21
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26

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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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