Elliptical Basket, Large

Basic Information

• Brand Name: Elliptical Basket, Large
• Primary DI: 00816207020433
• Version / Model: BGE-1622L
• Catalog Number: BGE-1622L
• Company Name: ENDO-THERAPEUTICS, INC.
• Labeler DUNS: 825239189
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 42b08555-b1ce-4f32-8682-d9629bf3b307
• Distribution End Date: 2019-11-04

Device Description

Endoscopic retrieval device, large elliptical basket

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46454	Gastrointestinal/airway foreign body retrieval basket, single-use	A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816207020430	GS1	box	10	Not in Commercial Distribution	2019-11-04
Primary	00816207020433	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K800970	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Basket Size Elliptical 30 mm
Device Size Text, specify			Min Channel 2.8 mm
Outer Diameter	2.4	Millimeter
Length	220	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry