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300 Flex-G Laser Fiber with Extended Length Sheath

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
300 Flex-G Laser Fiber with Extended Length Sheath FDA UDI
Generic Name
General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name
300 Flex-G Laser Fiber with Extended Length Sheath FDA UDI
Model / Reference
KS-0300S-FT-SH0-BLU-1 FDA UDI
Description
300 Flex-G Laser Fiber with Extended Length Sheath FDA UDI

Identifiers

Catalog Number
10914 FDA UDI
Primary DI / UDI-DI
00810077630303 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical laser system beam guide, single-use 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

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 300 Micrometer FDA UDI

Category: General/multiple surgical laser system beam guide, single-use

300 Flex-G Laser Fiber with Extended Length Sheath 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, single-use.

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 77dc74a1-ca65-4014-bd73-87c23974c544 37 fields · synced May 30, 2026