Catalog Number

-

Brand Name

MAX-JECT DENTAL NEEDLES

Version/Model Number

6070541355

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

DZM

Product Code Name

Needle, Dental

Public Device Record Key

5b1465d0-5b0e-420a-93ea-39240fe00247

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

D89260705413552

Quantity per Package

5000

Contains DI Package

D89260705413551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case