Disposable Universal silicone infusion line for 23 gauge / 0.6 mm cannula system

FDA UDI

Class I (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name: Disposable Universal silicone infusion line for 23 gauge / 0.6 mm cannula system FDA UDI
Generic Name: Ophthalmic cannulation set, single-use FDA UDI
Model / Reference: 1279.IA FDA UDI

Identifiers

Catalog Number: 1279.IA FDA UDI
Primary DI / UDI-DI: 08717872003214 FDA UDI
FDA Product Code: NGY FDA UDI
GMDN Term: Ophthalmic cannulation set, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic cannulation set, single-use

Disposable Universal silicone infusion line for 23 gauge / 0.6 mm cannula system by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I…

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

FDA UDI ed960a81-5de6-417f-88b7-7b8faf3eb9da 33 fields · synced May 31, 2026