FDA.reportPublic FDA data

MT

Primary DI
16932503524053
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
FWB-15/80-6/18-M
Device description
the balloon diameter is 15-16.5-18mm, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNQDilator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503524053PackageGS110In Commercial Distribution
26932503524050PackageGS110In Commercial Distribution
56932503524051PackageGS12In Commercial Distribution
66932503524058PackageGS125In Commercial Distribution
06932503524056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250352405316932503524053
2693250352405026932503524050
5693250352405156932503524051
6693250352405866932503524058
06932503524056069325035240566932503524056

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter15Millimeter
Balloon Diameter16.5Millimeter
Balloon Diameter18Millimeter
Balloon Length8Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260206311966BougieCap POvesco Endoscopy AGKNQ2026-01-16
56932503524013Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524020Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524037Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524044Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524051Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524068Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524075ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524082ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524099ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524105ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524129ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524143ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524150ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
00724995244545LumiflexUS EndoscopyKNQ2025-06-03
00724995244552LumiflexUS EndoscopyKNQ2025-06-03
00724995244569LumiflexUS EndoscopyKNQ2025-06-03
00724995244583LumiflexUS EndoscopyKNQ2025-06-03
00724995244590LumiflexUS EndoscopyKNQ2025-06-03
00724995244613LumiflexUS EndoscopyKNQ2025-06-03
00724995244644LumiflexUS EndoscopyKNQ2025-06-03
00724995244668LumiflexUS EndoscopyKNQ2025-06-03
00724995244675LumiflexUS EndoscopyKNQ2025-06-03
00724995244682LumiflexUS EndoscopyKNQ2025-06-03
16932503520673Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520680Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520697Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520765Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520772Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520789Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30