Zutron Medical

Basic Information

• Brand Name: Zutron Medical
• Primary DI: 00817658021178
• Version / Model: Endoscopy Procedure Kit
• Catalog Number: ZUTR40040
• Company Name: ZUTRON MEDICAL, L.L.C.
• Labeler DUNS: 962532441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-28
• Public Version: 1
• Public Version Date: 2023-08-07
• Public Version Status: New
• Public Device Record Key: ab85e6ab-2c74-4e56-8212-bb80ae8da0cb

Device Description

Endoscopy Kit-Basin, Vented Bag, Gauze, Biopsy Port Cover, Sponge, Zzyme, Lube, Channel Brush, Scope Tip Protector, Suction Tubing, Transport Tote

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61950	Endoscopy preparation kit	A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817658021185	GS1	Case	25	In Commercial Distribution
Primary	00817658021178	GS1

Customer Contacts

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