Luer Loc Tips - Luer Loc Tips are used to dispense adhesive from - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

Device Description: Luer Loc Tips are used to dispense adhesive from a luer lok syringe. Qty 60 tips

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More Product Details

Catalog Number

LLTIPS

Brand Name

Luer Loc Tips

Version/Model Number

LLTIPS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2016

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KXR

Product Code Name

Applicator, Resin

Device Record Status

Public Device Record Key

8b78def0-91af-4d03-8d25-091cf6b8db62

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

August 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 279