AccessGUDID - DEVICE: Cornisol (00803878044226)

GUDID

Device Identifier (DI) Information

Brand Name: Cornisol
Version or Model: Cornisol
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AUROLAB

Primary DI Number: 00803878044226
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 677319965 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYX	Media, Corneal Storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221759	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dabb457a-f160-43a6-98dc-c63be701fbdf
Public Version Date: July 05, 2023
Public Version Number: 1
DI Record Publish Date: June 27, 2023