FDA.reportPublic FDA data

ELMED

Primary DI
00842180161221
Brand
ELMED
Company
ELMED INCORPORATED
Model
25-1011SM-65
Catalog number
25-1011SM-65
Device description
SPECIAL INSTRUMENT: NEURO SHUNT GUIDE 65CM X 40MM DIA., W/HOLE IN TIP
Published
2023-02-10
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
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180161221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180161221008421801612218421801612210842180161221

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
00198506092183ELMED INCORPORATEDST5352077ST53520772026-07-29
00198506092343ELMED INCORPORATEDST5501380MST5501380M2026-07-29
00198506092350ELMED INCORPORATEDST3510800800ST35108008002026-07-29
00198506092640ELMED INCORPORATEDSTST5250541STST52505412026-07-29
00198506093197ELMED INCORPORATEDST7511814ST75118142026-07-29
00198506093487ELMED INCORPORATEDST233985ST2339852026-07-29
00198506093494ELMED INCORPORATEDST231006TST231006T2026-07-29
00198506093500ELMED INCORPORATEDST234215SSST234215SS2026-07-29
00198506093517ELMED INCORPORATEDST235066ST2350662026-07-29
00198506093524ELMED INCORPORATEDST231875DST231875D2026-07-29
00198506093531ELMED INCORPORATEDST234558ST2345582026-07-29
00198506093548ELMED INCORPORATEDST235930ST2359302026-07-29
00198506093555ELMED INCORPORATEDST23742503ST237425032026-07-29
00198506093562ELMED INCORPORATEDST5250223ST52502232026-07-29
00198506093579ELMED INCORPORATEDSTF9932 FSTF9932 F2026-07-29
00198506093586ELMED INCORPORATEDST1109400ST11094002026-07-29
00198506093593ELMED INCORPORATEDST420958ST4209582026-07-29
00198506093609ELMED INCORPORATEDST3315705ST33157052026-07-29
00198506093616ELMED INCORPORATEDST3380118ST33801182026-07-29
00198506093630ELMED INCORPORATEDST3155NUTST3155NUT2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411558MillenniumAvalign Technologies, Inc.HAO2026-08-07
00190776407537MillenniumAvalign Technologies, Inc.HAO2026-08-03
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00810220800515Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00190776407377MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776407384MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776400286MillenniumAvalign Technologies, Inc.HAO2026-07-17
04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17
00190776400231MillenniumAvalign Technologies, Inc.HAO2026-07-16
00190776395445MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395735MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395742MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395759MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
04946329056440CEA Scissors 170 mm, 35 deg. Downward CvdMIZUHO CORPORATIONHAO2026-05-29