Catalog Number

20971001

Brand Name

ACE

Version/Model Number

20971001

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)

Yes

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

78347a97-a680-4dff-a9c2-5a984f554844

Public Version Date

November 27, 2019

Public Version Number

2

DI Record Publish Date

October 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-