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Cook

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems FDA UDI
Model / Reference
G25295 FDA UDI
Description
Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems FDA UDI

Identifiers

Catalog Number
HLF-S365-HSMA FDA UDI
Primary DI / UDI-DI
00827002252950 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Cook by Cook Incorporated — 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
Cook Incorporated

Sources (1)

  • FDA UDI f2153d2e-acb8-48e2-bb32-1b928cff6670 36 fields · synced Jun 6, 2026