FDA.reportPublic FDA data

Hemorrhoidal Multi-Band Ligator with Anoscope

Primary DI
06951862291560
Brand
Hemorrhoidal Multi-Band Ligator with Anoscope
Company
Changzhou Health Microport Medical Device Co., Ltd
Model
HM/601-5-B
Device description
This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Published
2017-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
06951862291560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951862291560069518622915606951862291560

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligation setA collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547654578
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951862236653Stone Extraction BasketsHM/113-2.4/16002017-06-22
06951862236660Stone Extraction BasketsHM/113-2.4/18002017-06-22
06951862236677Stone Extraction BasketsHM/113-2.4/23002017-06-22
06951862291539Hemorrhoidal Multi-Band Ligator with Anoscope HM/601-3-A2017-06-22

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