Quinelato

Basic Information

• Brand Name: Quinelato
• Primary DI: 07898506814541
• Version / Model: QR.170.05
• Catalog Number: QR.170.05
• Company Name: Schobell Industrial Ltda
• Labeler DUNS: 899060826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: 8f82f6b1-7248-4cca-811f-d11d8f197de4

Device Description

Bakes gall duct dilators n° 5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13509	Gallstone scoop	A hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898506814541	GS1