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DMEK Surgical Disposable Set

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
DMEK Surgical Disposable Set FDA UDI
Generic Name
Donor cornea delivery set FDA UDI
Model / Reference
50.2200 FDA UDI

Identifiers

Catalog Number
50.2200 FDA UDI
Primary DI / UDI-DI
08717872018164 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Donor cornea delivery set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Donor cornea delivery set

DMEK Surgical Disposable Set by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Donor cornea delivery set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI b4df1a52-bbed-41cf-9090-a707f381952f 33 fields · synced May 30, 2026