FDA.reportPublic FDA data

ELMED

Primary DI
00842180192096
Brand
ELMED
Company
ELMED INCORPORATED
Model
25-1011SM-18
Catalog number
25-1011SM-18
Device description
"SPECIAL INSTRUMENT: NEURO SHUNT GUIDE AS PER CUSTOMERS SPECIFICATIONS, 4MM X 18"", W/ HOLE IN TIP"
Published
2024-04-16
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
00842180192096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180192096008421801920968421801920960842180192096

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, reusableA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.

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
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
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

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
00842180199446ELMEDELMED INCORPORATEDPIY2024-04-23
00842180199453ELMEDELMED INCORPORATEDPIY2024-04-23
00842180197732ELMEDELMED INCORPORATEDPIY2024-04-18
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