CRH O'Regan System 11-4120

GUDID 07540192000011

A case containing 20 Individually sealed kits, each kit containing one ligator with obturator, 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

• Primary Device ID: 07540192000011
• NIH Device Record Key: 117c9ae9-f181-4220-a616-d427d5fef7a9
• Commercial Distribution Status: 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	07540192000011 [Unit of Use]
GS1	17540192000018 [Primary]

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: 2020-10-09
• Device Publish Date: 2020-10-01