FDA.reportPublic FDA data

MT

Primary DI
16932503524091
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
FWB-10/80-6/18-S
Device description
the balloon diameter is 10mm, 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
16932503524091PackageGS110In Commercial Distribution
26932503524098PackageGS110In Commercial Distribution
56932503524099PackageGS12In Commercial Distribution
66932503524096PackageGS125In Commercial Distribution
06932503524094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250352409116932503524091
2693250352409826932503524098
5693250352409956932503524099
6693250352409666932503524096
06932503524094069325035240946932503524094

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 Diameter10Millimeter
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
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653405050865CONMEDConmed CorporationKNQ2026-03-24
46932503524016Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524023Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524030Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524047Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524054Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524061Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524078ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524085ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524092ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524108ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524122ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524146ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524153ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
00724995244576LumiflexUS EndoscopyKNQ2025-06-03
00724995244606LumiflexUS EndoscopyKNQ2025-06-03
00724995244620LumiflexUS EndoscopyKNQ2025-06-03
00724995244637LumiflexUS EndoscopyKNQ2025-06-03
00724995244651LumiflexUS EndoscopyKNQ2025-06-03
00724995244699LumiflexUS EndoscopyKNQ2025-06-03
00724995244705LumiflexUS EndoscopyKNQ2025-06-03
00724995244712LumiflexUS EndoscopyKNQ2025-06-03
20653405050787CONMEDConmed CorporationKNQ2023-10-10
04260206311386BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311409BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311423BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311447BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311461BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311485BougieCapOvesco Endoscopy AGKNQ2022-09-30
00884450383438Elation 5™Merit Medical Systems, Inc.KNQ2022-08-25