ABC Dilatation Balloon Catheter

Basic Information

• Brand Name: ABC Dilatation Balloon Catheter
• Primary DI: 46932503524085
• Version / Model: FWB-08/80-6/18-S
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Labeler DUNS: 530269083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-06
• Public Version: 1
• Public Version Date: 2025-12-15
• Public Version Status: New
• Public Device Record Key: f84a48b8-cea3-4fb5-aee4-3587617e716b

Device Description

the balloon diameter is 8mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter

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: 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
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	56932503524082	GS1	BOX	2	In Commercial Distribution
Primary	46932503524085	GS1
Package	66932503524089	GS1	CASE	25	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Balloon Diameter	8	Millimeter
Balloon Length	8	Centimeter