Catalog Number

-

Brand Name

Risuntech

Version/Model Number

OTS102

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

EFS

Product Code Name

Unit, Oral Irrigation

Public Device Record Key

6b3d10a8-a825-41e7-ace2-8aee328e3474

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

16955408701855

Quantity per Package

6

Contains DI Package

06955408701858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-