DEVICE: Tips (D79822TIPS101)

Device Identifier (DI) Information

Tips
22TIPS10
In Commercial Distribution
22TIPS10
RELIANCE ORTHODONTIC PRODUCTS INC
D79822TIPS101
HIBCC

10
113170088 *Terms of Use
22 Gauge Tips for use with compatible syringes.
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ECP Instrument, Ligature Tucking, Orthodontic
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

ceeb441d-5589-4962-9565-ee2d58910dc8
September 12, 2018
4
September 12, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D79822TIPS102 50 D79822TIPS101 In Commercial Distribution Bag
D79822TIPS103 15 D79822TIPS101 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D79822TIPS100 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
CLOSE