FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506093760
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
STESM451010JC
Catalog number
STESM451010JC
Device description
NEEDLE, CONE VENTRICULAR, W/LUER LOCK, 2 HOLE, 12 GAUGE, LARGER SIDE DISTAL HOLES
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCDCannula, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCDCannula, VentricularNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506093760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506093760001985060937601985060937600198506093760

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00198506093753ELMED INCORPORATEDELMED INCORPORATEDHCD2026-07-28
00840343727574Gen2SURGIX MEDICAL LLCHCD2026-04-23
00850047354716ClearPointClearpoint Neuro, Inc.HCD2026-03-10
00198506085031ELMED INCORPORATEDELMED INCORPORATEDHCD2025-09-05
00190776403003MillenniumAvalign Technologies, Inc.HCD2025-06-30
00190776401603MillenniumAvalign Technologies, Inc.HCD2025-06-11
00190776394325MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394332MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394356MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394363MillenniumAvalign Technologies, Inc.HCD2025-05-07
00190776394370MillenniumAvalign Technologies, Inc.HCD2025-05-07
00198506056697ELMED INCORPORATEDELMED INCORPORATEDHCD2025-01-27
00198506056680ELMED INCORPORATEDELMED INCORPORATEDHCD2024-10-29
G586N688847C0Novo SurgicalNOVO SURGICAL, INC.HCD2024-10-15
00198506061356ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00198506061363ELMED INCORPORATEDELMED INCORPORATEDHCD2024-09-11
00842180154018ELMEDELMED INCORPORATEDHCD2024-08-05
00198506060120ELMEDELMED INCORPORATEDHCD2024-07-23
00198506059568ELMEDELMED INCORPORATEDHCD2024-07-08
00198506058707ELMEDELMED INCORPORATEDHCD2024-07-05
00198506058325ELMEDELMED INCORPORATEDHCD2024-06-10
00842180199002ELMEDELMED INCORPORATEDHCD2024-04-23
00842180197855ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197862ELMEDELMED INCORPORATEDHCD2024-04-18
00842180197879ELMEDELMED INCORPORATEDHCD2024-04-18
G586N6888300Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
G586N6888420Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
G586N6888430Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
00842180179356ELMEDELMED INCORPORATEDHCD2023-10-05
00842180177253ELMEDELMED INCORPORATEDHCD2023-09-14