FDA.reportPublic FDA data

ELMED

Primary DI
00842180161313
Brand
ELMED
Company
ELMED INCORPORATED
Model
60-3501M
Catalog number
60-3501M
Device description
REUSABLE MEDIUM 45 DEG., ANGLE SHAFT WITH 3.75MM TIP RE-USABLE STAINLESS STEEL CORONARY PERFUSION CANNULA, 24CM OVERALL LENGTH, 3MM SUCTION TUBE O.D. 2MM, I.D TIP WITH 4 HOLES, FEMALE LUER LOCK
Published
2023-03-01
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180161313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180161313008421801613138421801613130842180161313

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
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
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704941593PILLINGTELEFLEX INCORPORATEDDWS2026-03-23
03661219509158DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511618DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511649DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511694DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511809DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511830DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515425DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515968DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528685DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528692DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528708DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528715DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219322184DELACROIX-CHEVALIERLANDANGERDWS2026-03-16
03661219323747DELACROIX-CHEVALIERLANDANGERDWS2026-03-13
04058749009538NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009811NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009873NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009903NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043082NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043099NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043143NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043150NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043167NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749047752NAFehling Instruments GmbH & Co. KGDWS2026-03-05
00198506088957ELMED INCORPORATEDELMED INCORPORATEDDWS2026-03-03
03661219010296LANDANGERLANDANGERDWS2026-03-02
03661219138471DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138518DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138556DELACROIX-CHEVALIERLANDANGERDWS2026-03-02