Scleral Shell

Basic Information

• Brand Name: Scleral Shell
• Primary DI: B863E661089V2627
• Version / Model: V2627
• Catalog Number: E661089
• Company Name: TEXAS EYE PROSTHETICS LLC
• Labeler DUNS: 016863467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-14
• Public Version: 1
• Public Version Date: 2020-04-22
• Public Version Status: New
• Public Device Record Key: b1e08264-8e1d-4e06-b86e-316ce0717db3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQT	Shell, Scleral	Ophthalmic	886.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34000	Scleral shell	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B863E661089V2627	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit