FDA.report

TactiSys™ Quartz Equipment

Primary DI
05415067034700
Brand
TactiSys™ Quartz Equipment
Company
ST. JUDE MEDICAL, INC.
Model
TSQ-RF-TFSE-CBL
Catalog number
TSQ-RF-TFSE-CBL
Device description
TactiFlex Radiofrequency Cable
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKDCABLE, ELECTRODE
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions

SubmissionSupplement
P220013000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P2200130001969-12-31

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415067034700PrimaryGS10

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes

TypeValueUnit
Length2Meter

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Keep dry. Keep away from sunlight
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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