FDA.reportPublic FDA data

Optisol

Primary DI
00757770601745
Brand
Optisol
Company
Bausch & Lomb Incorporated
Model
50006-OPT
Device description
CORNEAL STORAGE MEDIA (Box of 12)
Published
2024-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYXMedia, Corneal Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYXMedia, Corneal StorageUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770601745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770601745007577706017457577706017450757770601745

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08021118001552XTRA4AL.CHI.MI.A. SRLLYX2025-10-13
00803878044226CornisolAUROLABLYX2023-06-27
08021118000593EUSOL-CAL.CHI.MI.A. SRLLYX2022-12-22
00757770059881Bausch + LombBausch & Lomb IncorporatedLYX2022-02-04
20757770057874Bausch + LombBausch & Lomb IncorporatedLYX2016-09-25