Iris Retractor.

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: Iris Retractor. FDA UDI
Generic Name: Intraocular retractor, single-use FDA UDI
Model / Reference: 4020 FDA UDI

Identifiers

Catalog Number: 4020 FDA UDI
Primary DI / UDI-DI: 08717872009643 FDA UDI
FDA Product Code: HOC FDA UDI
GMDN Term: Intraocular retractor, 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: Intraocular retractor, single-use

Iris Retractor. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4a7c4332-bb1d-45ec-913d-397c95def63d 33 fields · synced May 30, 2026