DEVICE: Silicone Supra-Pubic Catheter (Ordinary Balloon) (04710961934158)

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Device Identifier (DI) Information

Silicone Supra-Pubic Catheter (Ordinary Balloon)
1890-0218

FORTUNE MEDICAL INSTRUMENT CORP.
04710961934158
GS1
10
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Suprapubic drainage catheter A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KOB Catheter, Suprapubic (And Accessories)
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Sterilization

Yes
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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 Status

In Commercial Distribution
March 11, 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: 14710961934155 CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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