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Smart Scope 1000 micrometer reusable laser fiber

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
Smart Scope 1000 micrometer reusable laser fiber FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
Smart Scope 1000 micrometer reusable laser fiber, packaged sterile FDA UDI
Model / Reference
SU-1000-DO FDA UDI
Description
Smart Scope 1000 micrometer reusable laser fiber, packaged sterile FDA UDI

Identifiers

Catalog Number
11780 FDA UDI
Primary DI / UDI-DI
B145117800 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

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

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 — 1000 Micrometer FDA UDI

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

Smart Scope 1000 micrometer reusable 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 5bb28376-1b5d-4a07-8ff0-546a5b1cec91 37 fields · synced May 29, 2026