Guardus

Basic Information

• Brand Name: Guardus
• Primary DI: 10816765012045
• Version / Model: SI711148
• Catalog Number: SI711148
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 5
• Public Version Date: 2020-03-31
• Public Version Status: Update
• Public Device Record Key: 08939296-3b45-4940-9fc3-c84fa27b1f99
• Distribution End Date: 2020-03-31

Device Description

The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
FED	endoscopic access overtube, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46687	Endoscopic overtube, single-use	A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816765012045	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040836	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	17	Millimeter
Outer Diameter	19.5	Millimeter
Length	50	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius