Bougie Dilator

Basic Information

• Brand Name: Bougie Dilator
• Primary DI: 06970057578415
• Version / Model: VDK-BO
• Company Name: Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
• Labeler DUNS: 544430136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 2
• Public Version Date: 2024-08-29
• Public Version Status: Update
• Public Device Record Key: a4586f4a-b47e-42c6-b9d4-6e6fdfc85f65

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNQ	Dilator, Esophageal	Gastroenterology, Urology	876.5365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46434	Oesophageal bougie, single-use	A cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970057578415	GS1