DEVICE: Flowtain (D798FTWING0)

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Device Identifier (DI) Information

Flowtain
FTWING
FTWING
RELIANCE ORTHODONTIC PRODUCTS INC
D798FTWING0
HIBCC
1
Flowtain syringe accessory to allow the user a more comfortable handle.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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

[?]
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

In Commercial Distribution
September 22, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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