SwirlNet

Basic Information

• Brand Name: SwirlNet
• Primary DI: 00816207021102
• Version / Model: ET2013
• Catalog Number: ET2013
• 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: 210b49f2-4227-4b69-952e-2ee29129a984

Device Description

Endoscopic Retrieval Net - Standard, Enteroscope

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	10816207021109	GS1	Box	5	In Commercial Distribution
Primary	00816207021102	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	350	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