SuperDART® ONE PASS™ Validated Channel Cleaning Kit

Basic Information

• Brand Name: SuperDART® ONE PASS™ Validated Channel Cleaning Kit
• Primary DI: 00666416121311
• Version / Model: 9399
• Catalog Number: 9399-25
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-06-13
• Public Version: 1
• Public Version Date: 2025-06-23
• Public Version Status: New
• Public Device Record Key: c198600d-10c5-4590-9ea1-34bb0fe559e6

Device Description

KIT BRUSH CLEANING 3 TO 4.5MM SuperDART SQUEEGEE SUCTION WELL (9293 + 9990). HIBC/UPN: M45393992

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38835	Surgical instrument/endoscope cleaning utensil, single-use	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. 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	00666416121304	GS1
Primary	00666416121311	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store cleaning device in original packaging at room temperature in a dry clean location away from direct sunlight.