Cornisol

Primary DI
00803878044226
Brand
Cornisol
Company
AUROLAB
Model
Cornisol
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.
Published
2023-06-27
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYXMedia, Corneal Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYXMedia, Corneal StorageUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221759000CornisolAurolab2022-10-05LYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00803878044226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00803878044226008038780442268038780442260803878044226

GMDN Terms#

Term, Definition table
TermDefinition
Corneal storage mediumA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+914523096100regulatory@aurolab.com

Regulatory Flags#

DUNS number
677319965
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10803878053058Aurotrocar ATS-23G2023-06-27
10803878036341NanocutS150022023-06-15
10803878044667AuroSleekC25222HT2023-06-15
10803878053201AuroSlimSK222152023-06-15
00803878028820Aurolon 6601N2020-06-22
00803878028837Aurolon 6602N2020-06-22
00803878028851Aurolon 6692N2020-06-22
00803878028868Aurolon 8401N2020-06-22
00803878028899Aurolon 8481N2020-06-22
00803878028905Aurosilk8481S2020-06-23
00803878028936Aurosilk8482S2020-06-23
00803878029032PolycrylA64092020-12-12
00803878029070AurosilkB44012020-06-23
00803878029087AurosilkB61052020-06-23
00803878029094AurosilkB61062020-06-23
00803878041638PolycrylA51082020-12-12
00803878067249Aurolon 6402N 2020-06-22
00803878029025PolycrylA61082020-09-16
00803878029049PolycrylA71022020-09-16
00803878029063PolycrylA81042020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08021118001552XTRA4AL.CHI.MI.A. SRLLYX2025-10-13
00757770601745OptisolBausch & Lomb IncorporatedLYX2024-03-04
08021118000593EUSOL-CAL.CHI.MI.A. SRLLYX2022-12-22
00757770059881Bausch + LombBausch & Lomb IncorporatedLYX2022-02-04
20757770057874Bausch + LombBausch & Lomb IncorporatedLYX2016-09-25