FDA.reportPublic FDA data

Sil-Ophtho

Primary DI
G6013500
Brand
Sil-Ophtho
Company
SIL-OPHTHO, LLC
Model
1
Catalog number
350
Device description
A special viscosity silicone oil used as a lubricant for the prosthetic eye
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
G6013500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eyeball prosthesis lubricantA material intended to be used for cleaning and lubricating an artificial eye. It is intended for use in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-381-8870orders@sil-ophtho.com

Regulatory Flags#

DUNS number
067465734
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G6011000Sil-Ophtho12024-03-14
G601100T0Sil-Ophtho1100T2024-03-14
G601350T0Sil-Ophtho1350T2024-03-14

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
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
G521V2623Artificial Eye, Plastic, CustomLegrand AssociatesHQH2023-10-18
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