Symblepharon Ring Conformer Large

Basic Information

• Brand Name: Symblepharon Ring Conformer Large
• Primary DI: M8722141608
• Version / Model: 21-416
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-16
• Public Version: 3
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: b22100bb-5e2c-4b03-a7d3-c144e4be2e34
• Distribution End Date: 2022-03-24

Device Description

The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQN	Conformer, Ophthalmic	Ophthalmic	886.3130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16073	Symblepharon ring, synthetic	An implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball. It is used occasionally in the case of, e.g., glaucoma, to keep raw surfaces separated. The device is made of synthetic material, e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, a polymer, or copolymer material.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M8722141608	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	24	Millimeter