Catalog Number

1025069

Brand Name

Safco absorbent points

Version/Model Number

1025069

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

EKN

Product Code Name

POINT, PAPER, ENDODONTIC

Public Device Record Key

6cd48d0b-5a97-41db-a986-ca7ca02a15be

Public Version Date

August 11, 2021

Public Version Number

2

DI Record Publish Date

July 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-