FDA.report

MT

Primary DI
16932503524077
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
FWB-06/80-6/18-S
Device description
the balloon diameter is 6mm, the balloon length is 80mm, the catheter diameter is 6 Fr., the working length is 1800mm, multistage dilation balloon catheter
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

Contact Domains

Product Codes

CodeName
KNQDilator, Esophageal

Product Code Classifications

CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16932503524077PackageGS110In Commercial Distribution
26932503524074PackageGS110In Commercial Distribution
56932503524075PackageGS12In Commercial Distribution
66932503524072PackageGS125In Commercial Distribution
06932503524070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693250352407716932503524077
2693250352407426932503524074
5693250352407556932503524075
6693250352407266932503524072
06932503524070069325035240706932503524070

GMDN Terms

TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Device Sizes

TypeValueUnit
Balloon Diameter6Millimeter
Balloon Length8Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
877-552-4027info@micro-tech-usa.com

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
16932503514658Biliary Plastic Stent SetBPDS-41114-0712/172026-03-20
16932503515617Biliary Plastic Stent SetBPDS-41114-0715/172026-03-20
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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Primary DIBrandCompanyProduct codePublished
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16932503520680Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
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16932503520765Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
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