N1101 Nexus Ligator 5 Pack

GUDID 00861815000469

The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx Medical Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

INX MEDICAL, LLC

Haemorrhoid ligation set

• Primary Device ID: 00861815000469
• NIH Device Record Key: 59b2c3d9-4a5c-4e31-b2ab-376900e37bbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N1101 Nexus Ligator 5 Pack
• Version Model Number: N1101-5
• Company DUNS: 028194294
• Company Name: INX MEDICAL, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 636-333-1010
• Email: spkilburn@inxmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861815000407 [Unit of Use]
GS1	00861815000469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131282

FDA Product Code

• FHN: Ligator, Hemorrhoidal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-26
• Device Publish Date: 2019-11-18

Devices Manufactured by INX MEDICAL, LLC

• 00861815000476 - N1101 Nexus Ligator 1 Pack: 2019-11-27 The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an
• 00861815000469 - N1101 Nexus Ligator 5 Pack: 2019-11-26The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx Medical Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.
• 00861815000469 - N1101 Nexus Ligator 5 Pack: 2019-11-26 The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an
• 00861815000414 - Nexus Hemorroid Ligator: 2019-08-12 The inx Medical Nexus™ Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with