Catalog Number

26557

Brand Name

EXEL Dental Needle

Version/Model Number

26557

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DZM

Product Code Name

Needle, Dental

Public Device Record Key

cd5ae114-0d45-47d4-a46e-03523c7a7578

Public Version Date

July 18, 2019

Public Version Number

1

DI Record Publish Date

July 10, 2019

Package DI Number

30020221265577

Quantity per Package

6

Contains DI Package

20020221265570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton