MBD-DM-BB-2

GUDID 26932503523152

the balloon diameter is 12-13.5-15mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 2300mm,with stainless steel

Micro-Tech (Nanjing) Co., Ltd.

Rectosphincteric balloon
Primary Device ID26932503523152
NIH Device Record Key9a41326e-ba15-46af-812a-29ea039c5b0e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMBD-DM-BB-2
Catalog NumberMBD-DM-BB-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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS116932503523155 [Primary]
GS126932503523152 [Package]
Contains: 16932503523155
Package: case [1 Units]
In Commercial Distribution

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.

16932503520673 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
16932503520680 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
16932503520697 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 18mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
16932503520765 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1000mm,with
16932503520772 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 1800mm,with
16932503520789 - Disposable Dilation Balloon2025-05-08 the balloon diameter is 20mm, the balloon length is 30mm, the catheter diameter is 7 Fr., and the working length is 2400mm,with
16932503534694 - Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel:
16932503534700 - Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)2025-05-08 Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel:

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