FDA.report

Med-Dyne

Primary DI
00817497022015
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
SGR60
Device description
60" GREEN SNAP ECG LEAD WIRE
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817497022015PrimaryGS10

GMDN Terms

TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Device Sizes

TypeValueUnit
Length60Inch

Sterilization Methods

Method

Contacts

PhoneEmail
502-429-4140SALES@MED-DYNE.COM

Regulatory Flags

DUNS number
826176703
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10817497020667Med-DyneGBK60-122016-09-26
00868795000205Med-DyneSCL8000SCL80002016-09-26
00868795000212Med-DyneSCL9000SCL90002016-09-26
00868795000229Med-DyneDEL3000DEL30002016-09-24
00868795000236Med-DyneDEL3000ADEL3000A2016-09-24
00868795000243Med-DyneDEL3000I2016-09-24
00868795000250Med-DyneDELF3000L2016-09-24
00817497020530Med-DyneG24AL2016-09-24
00817497020547Med-DyneG24AR2016-09-24
00817497020554Med-DyneG24AR-302016-09-24
00817497020561Med-DyneG24AS2016-09-24
00817497020578Med-DyneG24BS2016-09-24
00817497020585Med-DyneG4830-302016-09-24
00817497020592Med-DyneG48AS2016-09-24
00817497020608Med-DyneG536L2016-09-24
00817497020615Med-DyneG536S2016-09-24
00817497020622Med-DyneG60AS2016-09-24
00817497020844Med-DyneGE84-402016-09-24
00817497020851Med-DyneGE84-602016-09-24
00817497020998Med-DyneGL4024-402016-09-24

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20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
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06941691982920Orantech Orantech Inc.IKD2026-01-16