Catalog Number

10030-S

Brand Name

MEDICOM DENTICARE PRO-TRAY

Version/Model Number

10030-S

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

KMT

Product Code Name

TRAY, FLUORIDE, DISPOSABLE

Public Device Record Key

f89ab49a-ea1c-4f1e-b3ad-975060efc810

Public Version Date

September 16, 2021

Public Version Number

2

DI Record Publish Date

January 17, 2019

Package DI Number

20686864047753

Quantity per Package

15

Contains DI Package

10686864047756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case