FDA.reportPublic FDA data

Dallas Eye Prosthetics

Primary DI
00860015162816
Brand
Dallas Eye Prosthetics
Company
Dallas Eye Prosthetics
Model
1
Device description
Scleral Shell
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
CodeName
HQTShell, Scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQTShell, ScleralOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015162816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015162816008600151628168600151628160860015162816

GMDN Terms#

Term, Definition table
TermDefinition
Eyeball prosthesis, custom-madeAn 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 DIBrandModelCatalogPublished
00860015162809Dallas Eye Prosthetics12025-12-23
00860015162823Dallas Eye Prosthetics12025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286844925UniSyn Hip SystemShalby Advanced Technologies, Inc.HQT2025-05-14
G568V2627Scleral ShellTHOMPSON OCULAR PROSTHETICS, INC.HQT2025-03-10
B796V2627Shell, ScleralMIDWEST EYE LABORATORIES, INC.HQT2024-03-27
G519V2627Shell, ScleralMidwest Eye Laboratories Sioux Falls, LLCHQT2024-03-10
G290V2627Shell, ScleralMidwest Eye Laboratories Woodbury, LLCHQT2024-02-20
G542V26270Scleral ShellTHE EYE CONCERN, INC.HQT2024-01-10
G521V2627Scleral ShellLegrand AssociatesHQT2023-10-18
B863E661089V2627Scleral ShellTEXAS EYE PROSTHETICS LLCHQT2020-04-14