Device
Haemoband-PLUS Band Ligator is a class 2 latex free, single use, disposable instrument (medical device) used for the band ligation of internal 1st, 2nd, and 3rd degree hemorrhoids....
Manufacturer
Haemoband Surgical
Haemoband Surgical
Model: H1002
Catalog: H1002
DI: 05060937770006
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
Haemoband-PLUS Band Ligator is a class 2 latex free, single use, disposable instrument (medical device) used for the band ligation of internal 1st, 2nd, and 3rd degree hemorrhoids. The Haemoband-PLUS Band Ligator device must only be used by trained professionals.
The Haemoband-PLUS Band Ligator is an automated multi-ligator applicator device, comprising a one-piece plastic gun with four main components
• an insertion barrel or probe
• a protector firing nozzle, pre-loaded with four bands; and
• an innovative dual grip and firing mechanism
• universal suction connector
The device is to be attached to a standard suction supply via the universal connector on the handle. The trigger is then partially depressed to induce suction, then depressed fully to release the band onto the hemorrhoidal tissue secured. Grip from the trigger is then released with the next band automatically reloaded, ready for next band application.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
35d0a8fb-bc0a-4679-8bc2-347f0df48cfd
Distribution Status:
In Commercial Distribution
DUNS Number:
214125792
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
15060937770003
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05060937770006
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05060937770006
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35157
Name: Haemorrhoid ligator
Definition:
A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.
FDA Product Codes
FHN
Ligator, Hemorrhoidal
Premarket Submissions
Submission Number:
K091519
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
5
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature