Dallas Eye Prosthetics

Primary DI: 00860015162809
Brand: Dallas Eye Prosthetics
Company: Dallas Eye Prosthetics
Model: 1
Device description: Artificial Eye
Published: 2025-12-23
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
OTC: true

Product Codes#

Code, Name table
Code	Name
NCK	Button, Iris, Eye, Artificial

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
NCK	Button, Iris, Eye, Artificial	Ophthalmic	1

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860015162809	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860015162809	00860015162809	860015162809	0860015162809

GMDN Terms#

Term, Definition table
Term	Definition
Eyeball prosthesis, custom-made	An artificial substitute for the eyeball, resembling the anterior portion of the eye, made to individual specifications. It is usually constructed of glass or plastic and is intended to be inserted into a patient/user's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. This device is not intended to be implanted.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 148169683
Device count: 1
Premarket exempt: true
Lot or batch: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860015162816	Dallas Eye Prosthetics	1		2025-12-23
00860015162823	Dallas Eye Prosthetics	1		2025-12-23