FDA.report

MT

Primary DI
16932503532560
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
MBLS-XS-4F
Device description
Multiple Band Ligator Set,Applicable for endoscopic diameter(8.6~9.2)mm,4 ligation ring,Foreign markets,Band Type:Latex
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MNDLigator, Esophageal

Product Code Classifications

CodeDeviceSpecialtyClass
MNDLigator, EsophagealGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16932503532560PackageGS11In Commercial Distribution
26932503532567PackageGS11In Commercial Distribution
06932503532563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693250353256016932503532560
2693250353256726932503532567
06932503532563069325035325636932503532563

GMDN Terms

TermDefinition
Oesophageal endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
530269083
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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16932503515624Biliary Plastic Stent SetBPDS-41114-0718/172026-03-20
16932503515631Biliary Plastic Stent SetBPDS-41114-0805/222026-03-20
16932503515648Biliary Plastic Stent SetBPDS-41114-0807/222026-03-20
16932503515655Biliary Plastic Stent SetBPDS-41114-0809/222026-03-20
16932503515662Biliary Plastic Stent SetBPDS-41114-0812/222026-03-20
16932503515679Biliary Plastic Stent SetBPDS-41114-0815/222026-03-20
16932503515686Biliary Plastic Stent SetBPDS-41114-0818/222026-03-20
16932503515693Biliary Plastic Stent SetBPDS-41114-1005/222026-03-20
16932503515709Biliary Plastic Stent SetBPDS-41114-1007/222026-03-20
16932503515716Biliary Plastic Stent SetBPDS-41114-1009/222026-03-20
16932503515723Biliary Plastic Stent SetBPDS-41114-1012/222026-03-20
16932503515730Biliary Plastic Stent SetBPDS-41114-1015/222026-03-20
16932503515747Biliary Plastic Stent SetBPDS-41114-1018/222026-03-20
16932503515754Biliary Plastic Stent SetBPDS-41114-1105/222026-03-20
16932503515761Biliary Plastic Stent SetBPDS-41114-1107/222026-03-20
16932503515778Biliary Plastic Stent SetBPDS-41114-1109/222026-03-20
16932503515785Biliary Plastic Stent SetBPDS-41114-1112/222026-03-20
16932503515792Biliary Plastic Stent SetBPDS-41114-1115/222026-03-20

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