BONASTENT® Esophageal

Basic Information

• Brand Name: BONASTENT® Esophageal
• Primary DI: 08806369458603
• Version / Model: BER-1816
• Company Name: Sewoon Medical Co., Ltd.
• Labeler DUNS: 687784405
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-03
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: e687d415-5ea1-4f25-b62c-5f7c360cbc2d

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ESW	Prosthesis, Esophageal	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61751	Polymer-metal oesophageal stent	A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806369458603	GS1

Premarket Submissions

Submission Number	Supplement Number
K092144	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			160mm Stent Length
Device Size Text, specify			18mm Stent Diameter