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QLASE Adjustable Stand-Off Catheter

FDA UDI

Class II (US FDA UDI)

by Optical Integrity, Inc.

Identity

Trade Name
QLASE Adjustable Stand-Off Catheter FDA UDI
Generic Name
General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name
QLASE Adjustable Stand-Off Catheter FDA UDI
Model / Reference
OI-0750S-SF-CO0-LEX-1 FDA UDI
Description
QLASE Adjustable Stand-Off Catheter FDA UDI

Identifiers

Catalog Number
11515 FDA UDI
Primary DI / UDI-DI
00810077630488 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 — 750 Micrometer FDA UDI

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

QLASE Adjustable Stand-Off Catheter 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 487e00f8-0467-4c4c-ba62-53cb89b535cc 37 fields · synced May 30, 2026