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27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan FDA UDI
Generic Name
Ophthalmic fibreoptic light instrument, single-use FDA UDI
Model / Reference
3269.BE27 FDA UDI

Identifiers

Catalog Number
3269.BE27 FDA UDI
Primary DI / UDI-DI
08717872016320 FDA UDI
510(k) Number
K062895 FDA UDI
FDA Product Code
MPA FDA UDI
GMDN Term
Ophthalmic fibreoptic light instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic fibreoptic light instrument, single-use

27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II…

Similar devices

Also classified as Ophthalmic fibreoptic light instrument, single-use.

Cleared under the same submission

K062895 also covers:

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 ca258554-6b71-40d2-a1ff-4cecb93f66a6 34 fields · synced Jun 6, 2026