Catalog Number

0510

Brand Name

MEDICOM SAFEBASICS

Version/Model Number

0510

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DYN

Product Code Name

Mouthpiece, saliva ejector

Public Device Record Key

1ce7f965-b91c-4f56-a01e-5000f7c4317d

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Package DI Number

20686864008846

Quantity per Package

20

Contains DI Package

10686864008849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case