FDA.reportPublic FDA data

NA

Primary DI
10888551010641
Brand
NA
Company
STERILMED, INC.
Model
EPT5573S
Catalog number
EPT5573S
Device description
EP DIAGNOSTIC CATHETER POLARIS DX STEERABLE QUADRIPOLAR LONGEST
Published
2016-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551010641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855101064110888551010641

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)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551045698Reprocessed DECANAV EP Catheter, D CurveRR7D282CTRR7D282CT2024-11-15
10888551045704Reprocessed DECANAV EP Catheter, F CurveRR7F282CTRR7F282CT2024-11-15
10888551045179NARD128208RD1282082021-10-12
10888551045186NARD128210RD1282102021-10-12
10888551045193NARD128207RD1282072021-10-12
10888551045209NARD128211RD1282112021-10-12
10888551010313NADYO411641162019-08-13
10888551021531NAINS305630562019-08-13
10888551000048NALIN997199712019-08-13
10888551012928NAAUT173051AUT1730512020-10-09
10888551012935NAAUT174001AUT1740012020-10-09
10888551012959NAAUT174311AUT1743112020-10-09
10888551013000NAAUT176613AUT1766132020-10-09
10888551013031NAAUT176647AUT1766472020-10-09
10888551022934NASYN310.86SYN310.862020-10-09
10888551022941NASYN310.870SYN310.8702020-10-09
10888551022958NASYN310.880SYN310.8802020-10-09
10888551022965NASYN310.890SYN310.8902020-10-09
10888551022972NASYN310.971SYN310.9712020-10-09
10888551022989NASYN310.972SYN310.9722020-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898136078N/AINNOVATIVE HEALTH LLCNLH2025-09-17
10197344157310MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157327MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157334MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157341MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157358MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157365MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157372MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157389MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157396MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157402MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157419MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157426MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157433MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157440MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157457MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157464MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157471MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157488MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157495MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157501MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157518MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157525MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157532MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10197344157549MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-09-08
10841898135941N/AINNOVATIVE HEALTH LLCNLH2025-03-06
10888551045698Reprocessed DECANAV EP Catheter, D CurveSTERILMED, INC.NLH2024-11-15
10888551045704Reprocessed DECANAV EP Catheter, F CurveSTERILMED, INC.NLH2024-11-15
10841898128509N/AINNOVATIVE HEALTH LLCNLH2024-03-23
10841898128516N/AINNOVATIVE HEALTH LLCNLH2024-03-23