FDA.reportPublic FDA data

ELMED

Primary DI
00842180185906
Brand
ELMED
Company
ELMED INCORPORATED
Model
24-PVT0700
Catalog number
24-PVT0700
Device description
60CM LONG ROD FOR VASCULAR TUNNELER SET
Published
2024-02-20
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180185906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180185906008421801859068421801859060842180185906

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. 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
08022057015747JOSEPH LAMELAS Atrial Lift SystemCORCYM SRLDWS2026-02-03
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLDWS2026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerCORCYM SRLDWS2026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
G4533324301300PEAK MEDICALPeak Medical Distribution Inc.DWS2024-09-17
G586NS30105710Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G586NSCV511010Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G45352745404BC0PEAK MEDICALPeak Medical Distribution Inc.DWS2024-02-01
07898506818204QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818211QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818198QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506818228QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853106QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853113QuinelatoSchobell Industrial LtdaDWS2023-01-09
07899798203846QuinelatoSchobell Industrial LtdaDWS2022-12-16
ESOT001241NAS & T AGDWS2022-09-15
ESOT001251NAS & T AGDWS2022-09-15
ESOT002331NAS & T AGDWS2022-09-15
ESOT002481NAS & T AGDWS2022-09-15
ESOT002491NAS & T AGDWS2022-09-15
ESOT002501NAS & T AGDWS2022-09-15
ESOT002751NAS & T AGDWS2022-09-15
ESOT002761NAS & T AGDWS2022-09-15
ESOT003241NAS & T AGDWS2022-09-15
ESOT005011NAS & T AGDWS2022-09-15
ESOT005431NAS & T AGDWS2022-09-15
ESOT005741NAS & T AGDWS2022-09-15
ESOT005771NAS & T AGDWS2022-09-15
ESOT005881NAS & T AGDWS2022-09-15