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ScopeSafe™Laser Fiber

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
ScopeSafe™Laser Fiber FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
300 micrometer ScopeSafe laser fiber FDA UDI
Model / Reference
P00120300SS FDA UDI
Description
300 micrometer ScopeSafe laser fiber FDA UDI

Identifiers

Primary DI / UDI-DI
B145P00120300SS0 FDA UDI
510(k) Number
K022338 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
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 300 Micrometer FDA UDI

ScopeSafe™Laser Fiber by Optical Integrity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K022338 also covers:

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 50969bd4-6917-4983-a125-69e5df25d7aa 38 fields · synced Jun 1, 2026