Catalog Number

30010 PK8

Brand Name

MEDICOM PRO-MATRIX

Version/Model Number

30010 PK8

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

a4b3618e-d972-4975-9432-0e8de2bbe045

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 18, 2019

Package DI Number

20686864049818

Quantity per Package

8

Contains DI Package

10686864049811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case