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Excalibur MasterPulse Laser Fiber, 200-TRUE

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
Excalibur MasterPulse Laser Fiber, 200-TRUE FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
ForTec Excalibur MasterPulse True 200 micrometer laser fiber FDA UDI
Model / Reference
SU-200-TRUE-QEX FDA UDI
Description
ForTec Excalibur MasterPulse True 200 micrometer laser fiber FDA UDI

Identifiers

Primary DI / UDI-DI
B145117850 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical laser system beam guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 200 Micrometer FDA UDI

Category: General/multiple surgical laser system beam guide, reusable

Excalibur MasterPulse Laser Fiber, 200-TRUE by Optical Integrity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical laser system beam guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Optical Integrity, Inc.

Sources (1)

  • FDA UDI 5991404b-0e1a-4478-8857-6f69a548ae97 36 fields · synced Jun 8, 2026