MBD-EM-BA-2

GUDID 06932503523189

the balloon diameter is 15-16.5-18mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel

Micro-Tech (Nanjing) Co., Ltd.

Rectosphincteric balloon
Primary Device ID06932503523189
NIH Device Record Key4a03011e-bb77-42fa-96fe-9f8b82726ae0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMBD-EM-BA-2
Catalog NumberMBD-EM-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
GS106932503523189 [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.

16932503512210 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 25/ Outside diameter 2.5mm/ Front end shape/ no Rotation/ half Insu
16932503512234 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 30/ Outside diameter 2.5mm/ Front end shape/ no Rotation/ half Insu
16932503512241 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front end shape, no Rotation, no half In
16932503512258 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front end shape, no Rotation, half Insu
16932503512265 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front end shape, no Rotation, no half I
16932503512272 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front end shape, no Rotation, half Insu
16932503512289 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front end shape, no Rotation, no half In
16932503512296 - Sterile Sphincterotome2026-01-15 Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front end shape, no Rotation, half Insu

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