DEVICE: Flow Tain (D798FTLVTIPS1)

Device Identifier (DI) Information

Flow Tain
FTLVTIPS
Not in Commercial Distribution
FTLVTIPS
RELIANCE ORTHODONTIC PRODUCTS INC
D798FTLVTIPS1
HIBCC
November 15, 2016
10
113170088 *Terms of Use
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 syringe cannula, single-use A non-sterile, rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KXR Applicator, Resin
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FDA Premarket Submission

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

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

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Size Type Text
No Device Sizes
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Device Record Status

ec2502b8-7d05-4fa8-963c-9c6c4f4ef837
September 12, 2018
3
August 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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