FDA.report

Vitrectomy contact lens, single-use

Primary DI
53760087122201
Brand
Vitrectomy contact lens, single-use
Company
FCI S A S FCI 20 22
Model
DISPOSABLE PRISMATIC 30° LENS
Catalog number
S5.7030U
Device description
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03760087122206PrimaryGS10
53760087122201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760087122206037600871222063760087122206
5376008712220153760087122201

GMDN Terms

TermDefinition
Vitrectomy contact lens, single-useA sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.

Device Sizes

TypeValueUnit
Angle30degree

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
800-932-4202orders@fci-ophthalmics.com

Regulatory Flags

DUNS number
763408366
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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