Catalog Number

-

Brand Name

DART-Reach

Version/Model Number

301-REACH600

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

K070596,K070596

Product Code

CCT

Product Code Name

Applicator (Laryngo-Tracheal), Topical Anesthesia

Public Device Record Key

bc116a6e-c321-434b-94f5-77b22008416f

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

10841470103801

Quantity per Package

25

Contains DI Package

00841470103804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-