FDA UDI
In Commercial Distribution
🇺🇸 United States
EUSOL-C
DI: 08021118000593
·
Model: CSM 001-00
·
AL.CHI.MI.A. SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EUSOL-C
- Primary DI
- 08021118000593
- Version / Model
- CSM 001-00
- Company Name
- AL.CHI.MI.A. SRL
- Labeler DUNS
- 655640332
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-22
- Public Version
- 1
- Public Version Date
- 2022-12-30
- Public Version Status
- New
- Public Device Record Key
- a1e09dda-5008-45b5-8e62-aecbcb010391
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYX | Media, Corneal Storage | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18021118000590 | GS1 | Carton Box | 12 | In Commercial Distribution | |
| Primary | 08021118000593 | GS1 |
Customer Contacts
- Phone
- +390498962074
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- storage of human corneas at 2-8 C for up to 14 days