FDA.report

TactiCath¿™

Primary DI
07640157990040
Brand
TactiCath¿™
Company
ST. JUDE MEDICAL, INC.
Model
Quartz 75
Catalog number
PN-004075
Published
2014-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640157990040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640157990040076401579900407640157990040

GMDN Terms

TermDefinition
Cardiac radio-frequency ablation system catheterA sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge7French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, store at room temperature; keep dry

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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