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Su-200-True

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
SU-200-TRUE FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
200 micron laser fiber, single use, sterile FDA UDI
Model / Reference
11704 FDA UDI
Description
200 micron laser fiber, single use, sterile FDA UDI

Identifiers

Primary DI / UDI-DI
B145117040 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

Su-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 b828ed0d-5dd3-41c0-a490-d604a9af528d 36 fields · synced May 31, 2026