Hemorrhoid Ligator

Basic Information

• Brand Name: Hemorrhoid Ligator
• Primary DI: 00850348007335
• Version / Model: AL8000
• Catalog Number: AL8000
• Company Name: ADLER MICROMED, INC.
• Labeler DUNS: 080298464
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 2
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 13d12800-738e-45cf-948e-17e9a3e86817
• Distribution End Date: 2023-09-01

Device Description

Adler Hemorrhoid Ligator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: 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
35157	Haemorrhoid ligator	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850348007342	GS1		25	Not in Commercial Distribution	2023-09-01
Primary	00850348007335	GS1