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8000204

FDA UDI

Class II (US FDA UDI)

by Laser Peripherals Llc.

Identity

Trade Name
8000204 FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
LaseGuide™ Connect Edge 150u Laser Fiber PL FDA UDI
Model / Reference
8000204 FDA UDI
Description
LaseGuide™ Connect Edge 150u Laser Fiber PL FDA UDI

Identifiers

Catalog Number
8000204 FDA UDI
Primary DI / UDI-DI
00816469021377 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

8000204 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 1cb3895a-28a3-49cd-b326-78ece7a7a4ac 34 fields · synced Jun 8, 2026