Catalog Number

Adj. Depth Gauge

Brand Name

Depth Gauge

Version/Model Number

Adjustable Depth Gauge

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

b1922beb-9530-4f28-8e18-792050097727

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

April 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-