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Hb-550-Pl

FDA UDI

Class II (US FDA UDI)

by Laser Peripherals Llc.

Identity

Trade Name
HB-550-PL FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
550u Laser Fiber PL FDA UDI
Model / Reference
HB-550-PL FDA UDI
Description
550u Laser Fiber PL FDA UDI

Identifiers

Catalog Number
HB-550-PL FDA UDI
Primary DI / UDI-DI
00816469020387 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

Hb-550-Pl 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 b32641fa-b282-4c98-a514-fd20a82362ee 34 fields · synced Jun 7, 2026