Catalog Number

-

Brand Name

ZOLL-DENTAL

Version/Model Number

IP-SP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EIL

Product Code Name

GAUGE, DEPTH, INSTRUMENT, DENTAL

Public Device Record Key

f5d0fad7-cbb3-48d4-96b0-92fda3bac75c

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

January 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-