DEVICE: Flow Tain (D798FTLVTIPS1)

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Device Identifier (DI) Information

Flow Tain
FTLVTIPS
FTLVTIPS
RELIANCE ORTHODONTIC PRODUCTS INC
D798FTLVTIPS1
HIBCC
10
Flow Tain L.V. Tips are for dispensing paste from the Flow Tain syringe Pack of 10 X 22 gauge tips
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Dental restorative material cannula, single-use A non-sterile, rigid or semi-rigid device (dental tip) intended to channel a dental restorative material (e.g., amalgam, resin) from a single-barrelled parent device (e.g., syringe) to the intended site of dental application. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KXR Applicator, Resin
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Sterilization

No
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 at ambient conditions.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

Not in Commercial Distribution
August 15, 2016
November 15, 2016
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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
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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

[?]
Unit of Use DI Number: D798FTLVTIPS0 CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
630-773-4009
paulgropi@aol.com
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