FDA.reportPublic FDA data

Med-Dyne

Primary DI
00817497021230
Brand
Med-Dyne
Company
MED-DYNE, INC.
Model
GYL96
Device description
"96"" YELLOW GOLD CUP ELECTRODE 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817497021230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817497021230008174970212308174970212300817497021230

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length96Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-429-4140SALES@MED-DYNE.COM

Regulatory Flags#

DUNS number
826176703
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817497020667Med-DyneGBK60-122016-09-26
00817497020813Med-DyneGDBK482016-09-24
00868795000205Med-DyneSCL8000SCL80002016-09-26
00868795000212Med-DyneSCL9000SCL90002016-09-26
00817497020004Med-Dyne204BKBK01A22016-09-26
00817497020011Med-Dyne204WHWH01A204WHWH01A2016-09-26
00817497020042Med-Dyne381-0032016-09-26
00817497020059Med-Dyne381-0042016-09-26
00817497020066Med-Dyne381-0062016-09-26
00817497020073Med-Dyne381-0092016-09-26
00817497020080Med-Dyne381-0202016-09-26
00817497020097Med-Dyne630-0052016-09-26
00817497020103Med-Dyne630-0062016-09-26
00817497020110Med-Dyne630-0072016-09-26
00817497020127Med-Dyne630-0112016-09-26
00817497020134Med-Dyne630-011-182016-09-26
00817497020141Med-Dyne630-011-602016-09-26
00817497020158Med-Dyne630-011S2016-09-26
00817497020165Med-Dyne630-011S-602016-09-26
00817497020172Med-Dyne630-0122016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253019992KendallCardinal Health 200, LLCIKD2026-05-26
06946725550748APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725555316APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725571477APKAPK Technology Co.,Ltd.IKD2026-05-22
20653405017759CONMEDConmed CorporationIKD2026-03-24
20885380202480KendallCardinal Health 200, LLCIKD2026-03-20
20885380202497KendallCardinal Health 200, LLCIKD2026-03-20
B631ADX2GE61SureleadAuthentic MedicalIKD2026-03-13
B631DLSRPHP5L4F1SureLeadAuthentic MedicalIKD2026-03-13
B631EXTGE6PL8F1SureleadAuthentic MedicalIKD2026-03-13
B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
50885380208551CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
06946725509180APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509319APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509784APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509906APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513484APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513491APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513507APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513514APKAPK Technology Co.,Ltd.IKD2026-02-27
00850011306291High Density Tether 7.5mNEURALYNX, INC.IKD2026-02-19
00850011306307Tether Extension Cable Male-to-Male 3mNEURALYNX, INC.IKD2026-02-19
07613327688764N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-02-10
00849593025720AMCLifeSync CorporationIKD2026-02-05
00849593025737AMCLifeSync CorporationIKD2026-02-05
06941691983132Orantech Orantech Inc.IKD2026-01-29
06946725513200APKAPK Technology Co.,Ltd.IKD2026-01-23
06946725513217APKAPK Technology Co.,Ltd.IKD2026-01-23