Catalog Number

-

Brand Name

25K FS-10 PLASTIC INSERT/Darby

Version/Model Number

TM0004-982RT

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

K000510

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

5c5c892a-88ca-4179-ad14-871be13a6752

Public Version Date

January 04, 2021

Public Version Number

1

DI Record Publish Date

December 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-