Sterile-Z

Basic Information

• Brand Name: Sterile-Z
• Primary DI: 10618125189387
• Version / Model: 5575XLNS
• Catalog Number: 5575XLNS
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2020-09-04
• Public Version: 2
• Public Version Date: 2023-12-01
• Public Version Status: Update
• Public Device Record Key: f23ef5d2-8f05-4462-a4ef-2bbfe97aae04
• Distribution End Date: 2023-11-30

Device Description

Two Tier Surgical Back Table Cover

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00618125189380	GS1
Primary	10618125189387	GS1