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 Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium Corneal storage medium 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