ZOLL-DENTAL - PKT-3R - Zoll-Dental

Duns Number:005449822

Device Description: PKT-3R

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More Product Details

Catalog Number

-

Brand Name

ZOLL-DENTAL

Version/Model Number

OPWI-PKT3R

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

EIK

Product Code Name

CARVER, WAX, DENTAL

Device Record Status

Public Device Record Key

1b768126-56cd-4871-ac4c-f3c9188b3bef

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