AccessGUDID - DEVICE: EUSOL-C (08021118000593)

GUDID

Device Identifier (DI) Information

Brand Name: EUSOL-C
Version or Model: CSM 001-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AL.CHI.MI.A. SRL

Primary DI Number: 08021118000593
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 655640332 *Terms of Use

Device Description: EUSOL-C is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium piruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 143 ug/ml gentamicin sulfate. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. EUSOL-C is for storage of donor corneas at 2°C – 8°C for up to 14 days. It provides basic nutrients for cell maintenance and prevents tissue swelling preserving corneal thickness.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: storage of human corneas at 2-8 C for up to 14 days

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter

Device Record Status

Public Device Record Key: a1e09dda-5008-45b5-8e62-aecbcb010391
Public Version Date: December 30, 2022
Public Version Number: 1
DI Record Publish Date: December 22, 2022