Cornisol

Basic Information

• Brand Name: Cornisol
• Primary DI: 00803878044226
• Version / Model: Cornisol
• Company Name: AUROLAB
• Labeler DUNS: 677319965
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: dabb457a-f160-43a6-98dc-c63be701fbdf
• Distribution End Date: 2023-06-29

Device Description

CORNISOL is a sterile, buffered tissue culture media which is enhanced with polypeptides, an osmotic agent (dextran), Muco-polysaccharides, streptomycin sulfate and Gentamycin sulfate.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYX	Media, Corneal Storage	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
36094	Corneal storage medium	A material used for storage and transport of harvested corneas prior to transplantation to the recipient. This material is intended to maintain the viability of the corneal tissue. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00803878044226	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221759	000