Cornisol

GUDID 00803878044226

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

AUROLAB

Corneal storage medium

• Primary Device ID: 00803878044226
• NIH Device Record Key: dabb457a-f160-43a6-98dc-c63be701fbdf
• Commercial Distribution Discontinuation: 2023-06-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cornisol
• Version Model Number: Cornisol
• Company DUNS: 677319965
• Company Name: AUROLAB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com
• Phone: +914523096100
• Email: regulatory@aurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803878044226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221759

FDA Product Code

• LYX: Media, Corneal Storage

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by AUROLAB

• 00803878044226 - Cornisol: 2023-07-05CORNISOL is a sterile, buffered tissue culture media which is enhanced with polypeptides, an osmotic agent (dextran), Muco-polysaccharides, streptomycin sulfate and Gentamycin sulfate.
• 00803878044226 - Cornisol: 2023-07-05 CORNISOL is a sterile, buffered tissue culture media which is enhanced with polypeptides, an osmotic agent (dextran), Muco-polys
• 10803878053058 - Aurotrocar: 2023-07-05 Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which
• 10803878036341 - Nanocut: 2023-06-23 Nanocut Ophthalmic Surgical blades are an ophthalmic medical device and it is made from stainless steel grade 7C27Mo2.
• 10803878044667 - AuroSleek: 2023-06-23 AuroSleek Ophthalmic Surgical blades are an ophthalmic medical device and it is made from stainless steel grade .
• 10803878053201 - AuroSlim: 2023-06-23 AuroSlim Ophthalmic Surgical blades are an ophthalmic medical device and it is made from stainless steel grade.
• 10803878029039 - Polycryl: 2020-12-21 Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A64
• 10803878041635 - Polycryl: 2020-12-21 Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A51
• 00803878029025 - Polycryl: 2020-09-24 Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A61