FDA.reportPublic FDA data

N/A

Primary DI
57613327483944
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
33112
Catalog number
33112
Device description
Disposable 5 Lead Cable and Lead Wire System 3 Feet
Published
2019-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
37613327483940PackageGS110In Commercial Distribution
57613327483944PackageGS110In Commercial Distribution
10817357020417PreviousGS10
07613327483949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332748394037613327483940
5761332748394457613327483944
1081735702041710817357020417
07613327483949076133274839497613327483949

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reprocessedA 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 previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327679571N/AD128622D1286222025-05-21
07613327666762N/A9898031450519898031450512025-02-24
07613327666786N/A9898031990719898031990712025-02-24
57613327666804N/A9898031975119898031975112025-02-24
07613327666939N/A9898032111719898032111712025-02-24
57613327664084Philips Healthcare014R014R2025-02-11
57613327664091Philips Healthcare85900P85900P2025-02-11
57613327664107Philips Healthcare85900PST85900PST2025-02-11
57613327664114Philips Healthcare88901889012025-02-11
57613327383923N/AN/A5921-024-145RP2019-08-04
57613327383930N/AN/A5921-030-135RP2019-08-04
57613327383947N/AN/A5921-030-236RP2019-08-04

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
00849593025720AMCAdvantage Medical Electronics, LLCIKD2026-02-05
00849593025737AMCAdvantage Medical Electronics, LLCIKD2026-02-05
06941691983132Orantech Orantech Inc.IKD2026-01-29
06946725513200APKAPK Technology Co.,Ltd.IKD2026-01-23
06946725513217APKAPK Technology Co.,Ltd.IKD2026-01-23