PractiTip Neon A-W Syringe Tips - Air and Water Syringe tips for Dental Procedures - PRACTICON, INC.

Duns Number:119193803

Device Description: Air and Water Syringe tips for Dental Procedures

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More Product Details

Catalog Number

701791

Brand Name

PractiTip Neon A-W Syringe Tips

Version/Model Number

701791

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

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

ECB

Product Code Name

Unit, Syringe, Air And/Or Water

Device Record Status

Public Device Record Key

1ee5d535-e0f2-4285-9b75-66772e931b58

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Additional Identifiers

Package DI Number

00723896018576

Quantity per Package

10

Contains DI Package

00723896018569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"PRACTICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 93
2 A medical device with a moderate to high risk that requires special controls. 2