Eclipse

Basic Information

• Brand Name: Eclipse
• Primary DI: 00815430020647
• Version / Model: SZ02
• Catalog Number: SZ02-57RD
• Company Name: CLINICAL INNOVATIONS, LLC
• Labeler DUNS: 809524291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-11
• Public Version: 3
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: fff1e932-7e09-43c3-82b4-a64542005366

Device Description

Sizer with RFID Direct Marking

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
62321	Faecal-incontinence vaginal insert sizer	A non-sterile device intended to be used to determine the appropriate size of a faecal-incontinence vaginal insert for a particular patient. It is in the form of a semi-rigid ring that is inserted into the vagina as a guide to the size of the trial/final insert. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device for multi-patient use after appropriate cleaning/disinfection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815430020647	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150558	000

Device Sizes

Type	Value	Unit	Text
Width	57	Millimeter
Length	57	Millimeter