THD Bandy

Basic Information

• Brand Name: THD Bandy
• Primary DI: 08033737710685
• Version / Model: THD Bandy
• Catalog Number: 800079
• Company Name: THD SPA
• Labeler DUNS: 338430324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1b2fee0a-f57d-476a-82fd-09312d3f5f11

Device Description

THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46878	Haemorrhoid ligation set	A collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18033737710682	GS1		10	In Commercial Distribution
Primary	08033737710685	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093497	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	12.8	Millimeter
Length	154	Millimeter