Catalog Number

-

Brand Name

Genesis

Version/Model Number

G31035

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"

Yes

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

K101545

Product Code

EIL

Product Code Name

GAUGE, DEPTH, INSTRUMENT, DENTAL

Public Device Record Key

f437bd39-bccb-49b6-92ce-e7e42d14cce5

Public Version Date

March 25, 2021

Public Version Number

4

DI Record Publish Date

May 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-