SteriGear

Basic Information

• Brand Name: SteriGear
• Primary DI: 01618125155384
• Version / Model: 28257
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 3
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: dfefefe8-23d4-41db-9763-66a5b7af7512
• Distribution End Date: 2022-09-22

Device Description

SteriGear Dome Bags Clear Polyethylene Sterile 1in x 1in x 1in 20 per Case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, surgical	General, Plastic Surgery	878.4370	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
Primary	01618125155384	GS1