FDA.reportPublic FDA data

Shell, Scleral

Primary DI
G290V2627
Brand
Shell, Scleral
Company
Midwest Eye Laboratories Woodbury, LLC
Model
V2627
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
G290V2627PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scleral shellA custom-made prosthesis (a flush-fitting shell) that is used as a cosmetic artificial eye to cover a deformed or disfigured/unsightly blind eye, or over an eviscerated globe. It is made to suit a specific patient/user and will have the cosmetic representation to match the user's contra lateral real eye. It will be worn while the user is in public and normal waking hours. This is reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6517394111info@midwesteyelabs.com

Regulatory Flags#

DUNS number
809338473
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G290V2628Ophthalmic ConformerV2628D1208102024-02-20
G290V2623Eye, Artificial, Non-CustomV26232024-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015162816Dallas Eye ProstheticsDallas Eye ProstheticsHQT2025-12-23
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
G542V26270Scleral ShellTHE EYE CONCERN, INC.HQT2024-01-10
G521V2627Scleral ShellLegrand AssociatesHQT2023-10-18
B863E661089V2627Scleral ShellTEXAS EYE PROSTHETICS LLCHQT2020-04-14