ZOLL-DENTAL - Air/Water Syringe Tip Five Pack - Zoll-Dental

Duns Number:005449822

Device Description: Air/Water Syringe Tip Five Pack

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More Product Details

Catalog Number

-

Brand Name

ZOLL-DENTAL

Version/Model Number

Z-AWST-5

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

-

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

EHZ

Product Code Name

Evacuator, oral cavity

Device Record Status

Public Device Record Key

459a93ed-12f3-4d2a-9a90-51ed01635b63

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

March 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZOLL-DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2197