FDA.reportPublic FDA data

Reprocessed DECANAV EP Catheter, D Curve

Primary DI
10888551045698
Brand
Reprocessed DECANAV EP Catheter, D Curve
Company
STERILMED, INC.
Model
RR7D282CT
Catalog number
RR7D282CT
Device description
Reprocessed DECANAV EP Catheter, D Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLHCatheter, recording, electrode, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLHCatheter, Recording, Electrode, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240826000Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc.2024-10-11NLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551045698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855104569810888551045698

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, reprocessedA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15
10888551045445NASYN03.312.410SYN03.312.4102019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344020973MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344020980MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344021000MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043439MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043446MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043453MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043460MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043477MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043484MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043491MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043514MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043538MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043545MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043552MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043569MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043583MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043590MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043606MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043613MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043620MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043637MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043651MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043668MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043675MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043682MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043699MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043705MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043712MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043729MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043736MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15