Sani-Tip® - Sani-Tip® Disposable Air/Water Syringe Tip. - Dentsply Professional

Duns Number:144140845

Device Description: Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and 250 Sani- Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and 250 Sani-Shield® Sleeves.

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More Product Details

Catalog Number

-

Brand Name

Sani-Tip®

Version/Model Number

122215

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Device Record Status

Public Device Record Key

e3550e8d-15c1-4b12-8945-4457c7a9bde9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 27, 2017

Additional Identifiers

Package DI Number

D0031222152

Quantity per Package

40

Contains DI Package

D0031222151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DENTSPLY PROFESSIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 156