MBD-EM-BB-2

GUDID 26932503523190

the balloon diameter is 15-16.5-18mm,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 ID26932503523190
NIH Device Record Key3999d78e-71fa-4977-bbb6-77fe7c556f69
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMBD-EM-BB-2
Catalog NumberMBD-EM-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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS116932503523193 [Primary]
GS126932503523190 [Package]
Contains: 16932503523193
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.

16932503552056 - ADVANTIS(TM) Polypectomy Snare2024-11-18 Double color handle,Oval(FTS),Diameter is 15 mm,outer diameter is 7Fr,working length is 2300mm,Rotatable
16932503552063 - ADVANTIS(TM) Polypectomy Snare2024-11-18 Double color handle,Oval(FTS),Diameter is 20 mm,outer diameter is 7Fr,working length is 2300mm,Rotatable
16932503510131 - Sterile Hydro-Slide Guidewire2024-11-11 The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.025i
16932503510148 - Sterile Hydro-Slide Guidewire2024-11-11 The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.018i
16932503510155 - Sterile Hydro-Slide Guidewire2024-11-11 The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface,0.025in
16932503510162 - Sterile Hydro-Slide Guidewire2024-11-11 The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.018i
16932503530863 - Lockado(TM) Repositionable Hemostasis Clip2024-10-11 Open width11±1mm the max OD of insertion part 2.6mm working length 2350mm coated, single pickling wire, 10 pcs in the box Open
46932503530338 - SureClip(®MINI) Repositionable Hemostasis Clip2024-10-10 Open width8+2/0mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the box, single rotation wire

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