Schaerer

Basic Information

• Brand Name: Schaerer
• Primary DI: 07466532979116
• Version / Model: 71107
• Catalog Number: 71107
• Company Name: DAS Medical International SRL
• Labeler DUNS: 817435655
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 579d9877-58ba-4fe6-b06b-d870825538dc

Device Description

Urology Drain Bag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYH	Table, Cysto, Non-Electrical	Gastroenterology, Urology	876.4890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61677	Urological fluid funnel	A device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17466532979113	GS1	Case	12	In Commercial Distribution
Primary	07466532979116	GS1

Customer Contacts

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