DEVICE: Silicone T Drainage Set With Eyes (04711182606435)
Device Identifier (DI) Information
Silicone T Drainage Set With Eyes
1910-8216
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
1910-8216
In Commercial Distribution
FORTUNE MEDICAL INSTRUMENT CORP.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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10696 | Biliary drain |
A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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GCA | Catheter, Biliary, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
95562ad5-179d-4131-9586-1d905a0c5142
October 24, 2023
4
March 25, 2016
October 24, 2023
4
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 |
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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:
14711182606432
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined