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
Primary Device ID07540192000011
NIH Device Record Key117c9ae9-f181-4220-a616-d427d5fef7a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRH O'Regan System
Version Model Number11-4120
Catalog Number11-4120
Company DUNS243137838
Company NameCRH Medical Corporation
Device Count20
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540192000011 [Unit of Use]
GS117540192000018 [Primary]

FDA Product Code

FHNLigator, Hemorrhoidal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01