Eclipse

Basic Information

• Brand Name: Eclipse
• Primary DI: 00815430020197
• Version / Model: EC02
• Catalog Number: EC02-76EPR
• Company Name: CLINICAL INNOVATIONS, LLC
• Labeler DUNS: 809524291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: a01cb0bd-f5f6-479a-bb30-c1290aa46d63

Device Description

Eclipse Insert

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJH	Dynamic Rectal Control System	Gastroenterology, Urology	876.5930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62319	Faecal-incontinence vaginal insert	A non-sterile inflatable device intended to be inserted into the vagina and inflated/deflated to assist bowel evacuation regulation, as a treatment for faecal incontinence. It consists of a semi-rigid base, an inflatable balloon, valve, and optional external tubing. The balloon is inflated to occlude the adjacent rectal lumen to prevent stool leakage, and deflated to allow normal passage of stool. The device is used therapeutically for over a long-term period (typically less than 1 year), and may be removed/replaced by the patient. This is a single-patient reusable device after appropriate cleaning/disinfection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815430020197	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150558	000

Device Sizes

Type	Value	Unit	Text
Width	76	Millimeter
Length	83	Millimeter
Height	54	Millimeter