KERASAVE

Primary DI
08021118001408
Brand
KERASAVE
Company
AL.CHI.MI.A. SRL
Model
KER 001-00
Device description
Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. 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.It provides basic nutrients for cell maintenance.
Published
2022-12-05
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
QCWCorneal Storage Media With Preservatives Including Anti-Fungal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCWCorneal Storage Media With Preservatives Including Anti-FungalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200063000KerasaveAl.Chi.Mi.A. S.R.L2022-05-02QCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18021118001405PackageGS112In Commercial Distribution
08021118001408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1802111800140518021118001405
08021118001408080211180014088021118001408

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, Specify002-8°C

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08021118001552XTRA4EXT4 001-012025-10-13
08021118000593EUSOL-CCSM 001-002022-12-22