CRH O'Regan System 11-4120

GUDID 10754019200018

A case containing 20 Individually sealed kits, each kit containing one ligator, a bag of 3 latex bands, a loading cone and a patient brochure.

CRH Medical Corporation

Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator

• Primary Device ID: 10754019200018
• NIH Device Record Key: 96238c0c-14dc-476d-be3e-5cd52fa178c3
• Commercial Distribution Discontinuation: 2020-10-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CRH O'Regan System
• Version Model Number: 11-4120
• Catalog Number: 11-4120
• Company DUNS: 243137838
• Company Name: CRH Medical Corporation
• Device Count: 20
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00754019200011 [Unit of Use]
GS1	10754019200018 [Primary]

FDA Product Code

• FHN: Ligator, Hemorrhoidal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-16
• Device Publish Date: 2016-10-30