Catalog Number

BCA1411

Brand Name

ACHIEVE

Version/Model Number

BCA1411

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

e5dedc3c-e290-4823-8538-204388c7ad11

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 21, 2017

Package DI Number

50885403238077

Quantity per Package

5

Contains DI Package

10885403238079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case