Catalog Number

CA1620

Brand Name

ACHIEVE

Version/Model Number

CA1620

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

GDF

Product Code Name

GUIDE, NEEDLE, SURGICAL

Public Device Record Key

2e5b1b15-1f75-4163-a058-b1d6d3b7ae1e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

50885403088665

Quantity per Package

5

Contains DI Package

10885403088667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case