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

FDA UDI

Class II (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
DISPOSABLE VITRECTOMY SET FDA UDI
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. FDA UDI

Identifiers

Catalog Number
S5.7000U FDA UDI
Primary DI / UDI-DI
03760087122176 FDA UDI
FDA Product Code
HJK FDA UDI
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1385 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

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

Ophthalmic surgical procedure kit, non-medicated, single-use by Fci S A S Fci 20 22 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fci S A S Fci 20 22

Sources (1)

  • FDA UDI 115dd766-af2d-46ec-a1c6-6e478bbb8f69 35 fields · synced Jun 6, 2026