FDA UDI
In Commercial Distribution
🇺🇸 United States
XTRA4
DI: 08021118001552
·
Model: EXT4 001-01
·
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
- XTRA4
- Primary DI
- 08021118001552
- Version / Model
- EXT4 001-01
- 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
- 2025-10-13
- Public Version
- 1
- Public Version Date
- 2025-10-21
- Public Version Status
- New
- Public Device Record Key
- 1ebfe12c-f606-4a54-ac9e-19a06f8812a2
Device Description
XTRA4 is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8°C for up to 14 days. It is designed as a single use 20 mL solution in glass vials. XTRA4 is intended to be used only by physicians or highly skilled personnel such as eye bank operators.
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
- Yes
- 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 | 18021118001559 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 08021118001552 | GS1 |
Customer Contacts
- Phone
- +390498962074
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251320 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at 2-8°C (36-46°F) until ready for use. DO NOT FREEZE.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the cornea at 2-8°C (36-46°F) for up to 14 days.