DEVICE: Silicone Y Drainage Tube (04710961934462)

Device Identifier (DI) Information

Silicone Y Drainage Tube
1920-0020
In Commercial Distribution

FORTUNE MEDICAL INSTRUMENT CORP.
04710961934462
GS1

10
656763489 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
GCA Catheter, Biliary, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

83f64630-8677-4f2c-95ec-243fb891266c
March 29, 2018
2
March 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 14710961934469 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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