DEVICE: Advance (10827002588032)
Device Identifier (DI) Information
Advance
G58803
In Commercial Distribution
C-PTA5-35-80-6-4.0
COOK INCORPORATED
G58803
In Commercial Distribution
C-PTA5-35-80-6-4.0
COOK INCORPORATED
Advance Biliary Balloon Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45712 | Gastrointestinal/biliary dilation balloon catheter, non-medicated |
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, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCA | Biliary Catheter for stone removal that may also allow for irrigation and contrast injection |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K173414 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dark, dry, cool place. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ee8fac02-9acc-4027-ab99-7b38667667e7
December 23, 2024
2
February 09, 2021
December 23, 2024
2
February 09, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(812)330-5494
sharedservices@cookmedical.com
sharedservices@cookmedical.com