SteriGear

Basic Information

• Brand Name: SteriGear
• Primary DI: 00618125155453
• Version / Model: 27300
• Catalog Number: 27300
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-27
• Public Version: 2
• Public Version Date: 2022-11-02
• Public Version Status: Update
• Public Device Record Key: deaf2477-ee03-4455-9e40-07fe35f9e5ea

Device Description

SteriGear Urology Drain Bags Vinyl Sterile Fits Uroview 2600/2800 20 per Case

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMZ	Table, Cystometric, Electric	Gastroenterology, Urology	876.4890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61676	Urological fluid funnel, sterile	A sterile 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	10618125155450	GS1	Case	20	In Commercial Distribution
Primary	00618125155453	GS1
Previous	01618125155452	GS1