FDA.reportPublic FDA data

Ophthalmic surgical procedure kit, non-medicated, single-use

Primary DI
53760087122171
Brand
Ophthalmic surgical procedure kit, non-medicated, single-use
Company
FCI S A S FCI 20 22
Model
DISPOSABLE VITRECTOMY SET
Catalog number
S5.7000U
Device description
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760087122176PrimaryGS10
53760087122171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087122176037600871221763760087122176
5376008712217153760087122171

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602026-02-17
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602021-05-30
23700773707472MACULORHEXIS FORCEPS 27 G S9.6012.272021-05-30
23700773707489END GRASPING FORCEPS 27 G S9.6013.272021-05-30
23700773707496TANO FORCEPS 27 G S9.6017.272021-05-30
23700773707502pince super grip 23GS9.6018.232021-05-30
23700773707519pince super grip 25GS9.6018.252021-05-30
23700773707526pince super grip 27GS9.6018.272021-05-30
23700773721041TANO POLISHER,20G S9.6016.202021-05-29
23700773721058TANO POLISHER,23G S9.6016.232021-05-29
23700773721065TANO POLISHER,25G S9.6016.252021-05-29
23700773721225DISPOSABLE TANO FORCEPS 23GS9.6017.232021-05-30
23700773721232DISPOSABLE TANO FORCEPS 25GS9.6017.252021-05-30
23700773721249DISPOSABLE SERRATED FORCEPS 23GS9.6011.232021-05-30
23700773721256DISPOSABLE SERRATED FORCEPS 25GS9.6011.252021-05-30
23700773721263DISPOSABLE MACULORHEXIS FORCEPS, 23GS9.6012.232021-05-30
23700773721270DISPOSABLE MACULORHEXIS FORCEPS, 25GS9.6012.252021-05-30
23700773721287DISPOSABLE END-GRASPING FORCEPS, 23GS9.6013.232021-05-30
23700773721294DISPOSABLE END-GRASPING FORCEPS, 25GS9.6013.252021-05-30
23700773721324DISPOSABLE VERTICAL SCISSORS, 23GS9.6015.232021-05-30

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