FDA.reportPublic FDA data

ELMED

Primary DI
00198506058325
Brand
ELMED
Company
ELMED INCORPORATED
Model
45-1022M
Catalog number
45-1022M
Device description
"CONE BIOPSY NEEDLE SHARP OPEN END BLUNT OBTURATOR LUER LOCK 13G, ""M"" MODIDIED = NO HOLES.)"
Published
2024-06-10
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
HCDCannula, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCDCannula, VentricularNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506058325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506058325001985060583251985060583250198506058325

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
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
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
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
00190776373436MillenniumAvalign Technologies, Inc.HCD2023-06-23
00842180166936ELMEDELMED INCORPORATEDHCD2023-04-21