AccessGUDID - DEVICE: CRH O'Regan System (10754019200018)

GUDID

Device Identifier (DI) Information

Brand Name: CRH O'Regan System
Version or Model: 11-4120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11-4120
Company Name: CRH Medical Corporation

Primary DI Number: 10754019200018
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2020
Device Count: 20
Labeler D-U-N-S® Number*: 243137838 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHN	Ligator, Hemorrhoidal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96238c0c-14dc-476d-be3e-5cd52fa178c3
Public Version Date: October 16, 2020
Public Version Number: 3
DI Record Publish Date: October 30, 2016