SwirlNet

Basic Information

• Brand Name: SwirlNet
• Primary DI: 00816207021096
• Version / Model: ET2012
• Catalog Number: ET2012
• Company Name: ENDO-THERAPEUTICS, INC.
• Labeler DUNS: 825239189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-21
• Public Version: 1
• Public Version Date: 2022-09-29
• Public Version Status: New
• Public Device Record Key: 3a913193-9728-457d-9930-5822dc0e10fa

Device Description

Endoscopic Retrieval Net - Standard, Colonic

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: 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
FGX	Snare, Non-Electrical	Gastroenterology, Urology	876.4730	1

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	10816207021093	GS1	Box	10	In Commercial Distribution
Primary	00816207021096	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Net Size: 3.0 cm x 6.0 cm
Length	230	Centimeter
Device Size Text, specify			Min. Channel 2.8 mm
Outer Diameter	2.5	Millimeter

Storage Conditions

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