FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HQHEye, Artificial, Non-Custom

Product Code Classifications

CodeDeviceSpecialtyClass
HQHEye, Artificial, Non-CustomOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G6013500PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Total Volume15Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
877-381-8870orders@sil-ophtho.com

Regulatory Flags

DUNS number
067465734
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G6011000Sil-Ophtho12024-03-14
G601100T0Sil-Ophtho1100T2024-03-14
G601350T0Sil-Ophtho1350T2024-03-14

Other Devices Sharing Product Codes

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
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