StabilEyes

Basic Information

• Brand Name: StabilEyes
• Primary DI: 08717819039375
• Version / Model: STBL12US
• Catalog Number: STBL12US
• Company Name: Ophtec B.V.
• Labeler DUNS: 405048120
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-24
• Public Version: 5
• Public Version Date: 2019-09-09
• Public Version Status: Update
• Public Device Record Key: fe46d444-a5da-4416-85f6-d100636ba86c
• Distribution End Date: 2018-10-01

Device Description

Capsular Tension Ring 12.0 mm.

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
MRJ	Ring, Endocapsular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
42839	Capsular tension ring	A sterile, open-ended, non-optical circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules. The device, commonly known as a capsular tension ring (CTR) or an endocapsular ring, is permanently implanted in the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction) where it produces tension to distend the bag. It is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. Disposable devices associated with implantation (e.g., inserter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717819039375	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P030023	001
P030023	002
P030023	007

Device Sizes

Type	Value	Unit	Text
Outer Diameter	12	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 80 Degrees Fahrenheit