Catalog Number

-

Brand Name

NORDENT MANUFACTURING INC

Version/Model Number

ENSALSR

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

ELA

Product Code Name

Instrument, Hand, Calculus Removal

Public Device Record Key

35a3e20d-c463-433d-9cb0-84be37ef1118

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-