FDA.reportPublic FDA data

XTRA4

Primary DI
08021118001552
Brand
XTRA4
Company
AL.CHI.MI.A. SRL
Model
EXT4 001-01
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.
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K251320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251320000XTRA4Al.Chi.Mi.A. S.R.L2025-09-11LYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18021118001559PackageGS112In Commercial Distribution
08021118001552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1802111800155918021118001559
08021118001552080211180015528021118001552

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume20Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C (36-46°F) until ready for use. DO NOT FREEZE.
Special Storage Condition, Specify00Store the cornea at 2-8°C (36-46°F) for up to 14 days.

Contacts#

Phone, Email table
PhoneEmail
+390498962074info@alchimiasrl.com

Regulatory Flags#

DUNS number
655640332
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08021118000593EUSOL-CCSM 001-002022-12-22
08021118001408KERASAVEKER 001-002022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770601745OptisolBausch & Lomb IncorporatedLYX2024-03-04
00803878044226CornisolAUROLABLYX2023-06-27
08021118000593EUSOL-CAL.CHI.MI.A. SRLLYX2022-12-22
00757770059881Bausch + LombBausch & Lomb IncorporatedLYX2022-02-04
20757770057874Bausch + LombBausch & Lomb IncorporatedLYX2016-09-25