PIRANHA

Basic Information

• Brand Name: PIRANHA
• Primary DI: 04055207049099
• Version / Model: 49700103
• Catalog Number: 49700103
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-06-28
• Public Version: 4
• Public Version Date: 2018-12-24
• Public Version Status: Update
• Public Device Record Key: 6f9354cb-2779-4256-97b3-99fd680a5ad9
• Distribution End Date: 2017-06-29

Device Description

ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM for MORCESCOPE Storz, for morcellation following laser prostate enucleation, sterile

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FJK	SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46729	Tissue morcellation system	An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207049099	GS1
Unit of Use	04055207049730	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	385	Millimeter
Outer Diameter	4.8	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 70 Percent (%) Relative Humidity