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Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System. FDA UDI
Generic Name
Ophthalmic procedural light source unit FDA UDI
Model / Reference
1266.XD FDA UDI

Identifiers

Catalog Number
1266.XD FDA UDI
Primary DI / UDI-DI
08717872001081 FDA UDI
510(k) Number
K062895 FDA UDI
FDA Product Code
MPA FDA UDI
GMDN Term
Ophthalmic procedural light source unit 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic procedural light source unit

Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI…

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 4fc6a1c0-ab08-4dca-9788-9c81c44878f0 34 fields · synced Jun 8, 2026