Catalog Number

-

Brand Name

superDimension

Version/Model Number

SDAN2000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

51547597-019b-4183-b2c1-240d878a25c3

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

August 29, 2018

Package DI Number

20884521200507

Quantity per Package

5

Contains DI Package

10884521200500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE