Catalog Number

-

Brand Name

30K SL-10S-R PLUS INSERT

Version/Model Number

TM0103-142R

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

K052028

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Public Device Record Key

07b3da82-6fec-4125-9cea-0dd0fa796f15

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-