N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10841898113307
• Version / Model: N/A
• Catalog Number: 320002
• Company Name: INNOVATIVE HEALTH LLC
• Labeler DUNS: 015575953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bbb340ae-1e2c-4e33-9a67-b33371a8b014

Device Description

Orbiter ST Steerable Diagnostic EP Catheter 95 cm Small Curve 20 Electrodes 2-10-2 mm Spacing 7F

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NLH	Catheter, Recording, Electrode, Reprocessed	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46359	Cardiac mapping catheter, percutaneous, reprocessed	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841898113307	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161393	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 45 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 45 Degrees Celsius