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Rhapsody H-30

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Rhapsody H-30 FDA UDI
Generic Name
General/multiple surgical solid-state laser system FDA UDI
Device Name
Rhapsody H-30 Holmium Laser System FDA UDI
Model / Reference
G47625 FDA UDI
Description
Rhapsody H-30 Holmium Laser System FDA UDI

Identifiers

Catalog Number
HL-30E FDA UDI
Primary DI / UDI-DI
00827002476257 FDA UDI
510(k) Number
K172325 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical solid-state laser system 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

No

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: General/multiple surgical solid-state laser system

Rhapsody H-30 by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical solid-state laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 11ff9141-62e4-4b37-952a-66cacaf248e2 37 fields · synced Jun 8, 2026