FDA.reportPublic FDA data

CRH O'Regan System

Primary DI
17540192000018
Brand
CRH O'Regan System
Company
CRH Medical Corporation
Model
11-4120
Catalog number
11-4120
Device description
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.
Published
2020-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHNLigator, Hemorrhoidal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540192000018PrimaryGS10
07540192000011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019200001817540192000018
07540192000011075401920000117540192000011

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA 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.

Regulatory Flags#

DUNS number
243137838
Device count
20
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10754019200018CRH O'Regan System11-412011-41202016-10-30
07540192000011CRH O'Regan System11-412011-41202020-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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