FDA.reportPublic FDA data

Artificial Eye, Plastic, Custom

Primary DI
G521V2623
Brand
Artificial Eye, Plastic, Custom
Company
Legrand Associates
Model
V2623
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HQHEye, Artificial, Non-Custom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQHEye, Artificial, Non-CustomOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G521V2623PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
14849048759patrascan123@gmail.com

Regulatory Flags#

DUNS number
002306975
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G521V2627Scleral ShellV26272023-10-18
G521V2628Ophthalmic ConformerV26282023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
PROSV2623Soper Brothers CustomSoper Brothers, IncorporatedHQH2026-03-03
SHELLV2627Soper Brothers CustomSoper Brothers, IncorporatedHQH2026-03-03
G568V2623Artificial Eye, Plastic, CustomTHOMPSON OCULAR PROSTHETICS, INC.HQH2025-03-10
B796V2623Eye, Artificial, Non-CustomMIDWEST EYE LABORATORIES, INC.HQH2024-03-27
G6011000Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G601100T0Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G6013500Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G601350T0Sil-OphthoSIL-OPHTHO, LLCHQH2024-03-14
G519V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Sioux Falls, LLCHQH2024-03-10
G290V2623Eye, Artificial, Non-CustomMidwest Eye Laboratories Woodbury, LLCHQH2024-02-19
G542V26230Artificial EyeTHE EYE CONCERN, INC.HQH2024-01-10
00840329810528N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810535N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810542N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810559N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810566N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810573N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810580N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810597N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
00840329810603N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-21
B089B675600N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675610N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675620N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675630N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675650N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675660N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675670N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675680N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B089B675690N/ABLACK & BLACK SURGICAL, INC.HQH2022-09-12
B863E661087V2623Artificial Eye, Plastic, CustomTEXAS EYE PROSTHETICS LLCHQH2020-04-14