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SmartScope laser fiber

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
SmartScope laser fiber FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
365 micrometer SmartScope laser fiber, single use, sterile, round tip FDA UDI
Model / Reference
11559 FDA UDI
Description
365 micrometer SmartScope laser fiber, single use, sterile, round tip FDA UDI

Identifiers

Primary DI / UDI-DI
B145115590 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 — 365 Micrometer FDA UDI

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

SmartScope laser fiber 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 65666820-3512-49bb-90cc-9715e1d7bbbf 36 fields · synced Jun 8, 2026