Catalog Number

-

Brand Name

SmartNeedle® vascular access system

Version/Model Number

67503

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

1b444659-4563-4d47-a86f-1962a2956b3b

Public Version Date

November 11, 2019

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

M206675031

Quantity per Package

10

Contains DI Package

M206675030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box