Eclipse

Basic Information

• Brand Name: Eclipse
• Primary DI: 00815430020548
• Version / Model: RR02
• Catalog Number: RR02-MedLo
• 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: ed35470a-c1e2-4131-b150-6174c631d0ee

Device Description

Regulator

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
62320	Faecal-incontinence vaginal insert pump	A manually-powered air pump designed to inflate/deflate a faecal-incontinence vaginal insert used to assist bowel evacuation regulation, as a treatment for faecal incontinence. It includes a replaceable regulator which determines the maximum pressure of the insert balloon. 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	00815430020548	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150558	000