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Lg-365-E

FDA UDI

Class II (US FDA UDI)

by Laser Peripherals Llc.

Identity

Trade Name
LG-365-E FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
LaseGuide™ Edge 365u Laser Fiber FDA UDI
Model / Reference
LG-365-E FDA UDI
Description
LaseGuide™ Edge 365u Laser Fiber FDA UDI

Identifiers

Catalog Number
LG-365-E FDA UDI
Primary DI / UDI-DI
00816469021094 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Urogenital 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

No

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

No

FDA UDI

Category: Urogenital surgical laser system beam guide, single-use

Lg-365-E by Laser Peripherals Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urogenital 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
Laser Peripherals Llc.

Sources (1)

  • FDA UDI 2d3fb4d0-c2e2-4c4b-b717-833a4183ee59 34 fields · synced Jun 6, 2026