DEVICE: LoFric® (07392532131851)

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Device Identifier (DI) Information

LoFric®
40012
4001240
Dentsply Ih AB
07392532131851
GS1
1
Single Use Urinary Catheter LoFric Nelaton 16" 12FR
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Single-administration urethral drainage catheter A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EZD CATHETER, STRAIGHT
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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
Special Storage Condition, Specify: Store in a dry place at room temperature.
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Clinically Relevant Size

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Size Type Text
Length: 16 Inch
Catheter Gauge: 12 French
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Device Status

In Commercial Distribution
November 23, 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
07392532158995 4 07392532158988 In Commercial Distribution Transport Packaging
07392532158988 30 07392532131851 In Commercial Distribution
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)456-3742
info-lofric-usa@wellspect.com
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