Piranha

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: PIRANHA FDA UDI
Generic Name: Tissue morcellation system FDA UDI
Device Name: ROTATIONS-MORCELLATOR Ø 4.8MM WL 350MM for MORCESCOPE, for morcellation following laser prostate enucleation, reusable FDA UDI
Model / Reference: 8970011 FDA UDI
Description: ROTATIONS-MORCELLATOR Ø 4.8MM WL 350MM for MORCESCOPE, for morcellation following laser prostate enucleation, reusable FDA UDI

Identifiers

Catalog Number: 8970.011 FDA UDI
Primary DI / UDI-DI: 04055207044988 FDA UDI
FDA Product Code: FJL FDA UDI
GMDN Term: Tissue morcellation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 350 Millimeter FDA UDI
Outer Diameter — 4.8 Millimeter FDA UDI

Category: Tissue morcellation system

Piranha by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BLUEENDO — TROKAMED GmbH · Class II
Versacut Tissue Morcellator — Lumenis · Class II
BLUEENDO — TROKAMED GmbH · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Richard Wolf GmbH

Sources (1)

FDA UDI 870e3715-c138-4d43-97b4-0280a23519a2 36 fields · synced May 31, 2026