MBD-CM-BA-2

GUDID 06932503523103

the balloon diameter is 10-11-12mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel gu

Micro-Tech (Nanjing) Co., Ltd.

Rectosphincteric balloon
Primary Device ID06932503523103
NIH Device Record Key18aff279-ec3d-48d1-9dc8-ba7b4ac7506a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMBD-CM-BA-2
Catalog NumberMBD-CM-BA-2
Company DUNS530269083
Company NameMicro-Tech (Nanjing) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com

Device Dimensions

Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter
Balloon Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106932503523103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNQDilator, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-08

Devices Manufactured by Micro-Tech (Nanjing) Co., Ltd.

16932503513873 - Biliary Plastic Stent2026-03-09 TPU, Straight, 7Fr, 5cm
16932503513880 - Biliary Plastic Stent2026-03-09 TPU, Straight, 7Fr, 7cm
16932503513897 - Biliary Plastic Stent2026-03-09 TPU, Straight, 7Fr, 9cm
16932503513903 - Biliary Plastic Stent2026-03-09 TPU, Straight, 7Fr, 12cm
16932503514627 - Biliary Plastic Stent Set2026-03-09 TPU,Straight,7Fr,5cm working length with 1700mm introducer
16932503514634 - Biliary Plastic Stent Set2026-03-09 TPU,Straight,7Fr,7cm working length with 1700mm introducer
16932503514641 - Biliary Plastic Stent Set2026-03-09 TPU,Straight,7Fr,9cm working length with 1700mm introducer
16932503515310 - Biliary Plastic Stent2026-03-09 TPU, Straight, 7Fr, 15cm

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.