DEVICE: NA (06932503523196)
Device Identifier (DI) Information
NA
MBD-EM-BB-2
In Commercial Distribution
MBD-EM-BB-2
Micro-Tech (Nanjing) Co., Ltd.
MBD-EM-BB-2
In Commercial Distribution
MBD-EM-BB-2
Micro-Tech (Nanjing) Co., Ltd.
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 guide wire
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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Yes | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45712 | Gastrointestinal/biliary dilation balloon catheter |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KNQ | Dilator, Esophageal |
FGE | Catheter, Biliary, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d9bfc95e-bf67-4801-9f9d-26fa2d83645b
May 11, 2021
3
March 08, 2016
May 11, 2021
3
March 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined