Skytron

Basic Information

• Brand Name: Skytron
• Primary DI: 01618125175641
• Version / Model: 33155
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 5
• Public Version Date: 2023-03-03
• Public Version Status: Update
• Public Device Record Key: a666a2ae-8a24-46f2-a28a-e3906a2716f8
• Distribution End Date: 2023-03-02

Device Description

Skytron Urology Drain Bags Natural Polypropylene 1in x 1in x 1in 100 per Case

Device Characteristics

• Single Use: No
• 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: 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
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00618125175642	GS1		100	Not in Commercial Distribution	2023-03-02
Primary	01618125175641	GS1