FDA.reportPublic FDA data

Flexlens

Primary DI
00847835000023
Brand
Flexlens
Company
X-Cel Specialty Contacts
Model
Sphere
Device description
Flexlens Sphere Vial
Published
2026-01-22
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

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847835000023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847835000023008478350000238478350000230847835000023

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
048610864
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847835000184FlexlensPrism Sphere2026-02-25
00847835000177FlexlensMultifocal2026-01-22
00847835000016FlexlensSphere2026-01-22
00847835000061FlexlensTricurve Keratoconus2026-01-22
00847835000085FlexlensPiggyback2026-01-22
00847835000108FlexlensPRS2026-01-22
00847835000122FlexlensAphakic2026-01-22
00847835000146FlexlensAdult Aphakic2026-01-22
00847835000160FlexlensMultifocal2026-01-22
10847835000013FlexlensSphere2026-01-22
00847835000030FlexlensToric2026-01-22
00847835000047FlexlensARC2026-01-22
00847835000054FlexlensARC2026-01-22
10847835000068FlexlensTricurve Keratoconus2026-01-22
00847835000078FlexlensTricurve Keratoconus2026-01-22
10847835000082FlexlensPiggyback2026-01-22
00847835000092FlexlensPiggyback2026-01-22
10847835000105FlexlensPRS2026-01-22
00847835000115FlexlensPRS2026-01-22
10847835000129FlexlensAphakic2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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