High flow infusion line for 20, 23, 25 & 27G cannula system

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: High flow infusion line for 20, 23, 25 & 27G cannula system FDA UDI
Generic Name: Ophthalmic cannulation set, single-use FDA UDI
Model / Reference: 1279.HF FDA UDI

Identifiers

Catalog Number: 1279.HF FDA UDI
Primary DI / UDI-DI: 08717872018546 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

High flow infusion line for 20, 23, 25 & 27G cannula system by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA UDI — listed in…

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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 9950df19-eb57-416e-8e64-66e34f46d4db 33 fields · synced May 30, 2026