DEVICE: Silicone Y Drainage Tube (04710961934448)
Device Identifier (DI) Information
Silicone Y Drainage Tube
1920-0016
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
1920-0016
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
11307 | Biliary T drain |
A sterile, T-shaped, tubular device designed to establish a channel for the removal of fluid from a body cavity or anatomical region (usually the biliary tract). It is typically used in conjunction with, or as a component of, a closed drainage system using a low negative pressure through the drain lumen. It is typically made of silicone and has perforations along its distal end; it does not include any fluid collection bags/containers. It comes in various shapes and sizes. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCA | Catheter, Biliary, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K980917 | 000 |
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
f4e926a0-4d11-481f-8f14-c784103ada33
July 06, 2018
3
March 25, 2016
July 06, 2018
3
March 25, 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 |
---|---|---|---|---|---|
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:
14710961934445
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined