Medium Conformer with Holes (non-sterile)

Basic Information

• Brand Name: Medium Conformer with Holes (non-sterile)
• Primary DI: B091141681
• Version / Model: 14168
• Catalog Number: 14168
• Company Name: Gulden Ophthalmics Inc.
• Labeler DUNS: 002373249
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0ac77209-2cc1-4032-88c8-3642b5de433d

Device Description

Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops.

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
16065	Ophthalmic conformer	An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B091141681	HIBCC
Unit of Use	B091141680	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	0.94	Inch
Length	0.83	Inch