FDA.report

N/A

Primary DI
57613327481995
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
LW-309DS50/5AT
Catalog number
LW-309DS50/5AT
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

Related Records

Contact Domains

Product Codes

CodeName
IKDCABLE, ELECTRODE

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
57613327481995PackageGS125In Commercial Distribution
10817357020837PreviousGS10
07613327481990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5761332748199557613327481995
1081735702083710817357020837
07613327481990076133274819907613327481990

GMDN Terms

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

TypeValueUnit
Length50Inch

Sterilization Methods

Method

Contacts

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

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