Catalog Number

ACP16-195-20

Brand Name

AprioCore plus

Version/Model Number

ACP16-195-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K193268,K193268,K193268

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

14637ec3-59a1-4c8f-8a0a-58889e5e31d6

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Package DI Number

17350031350163

Quantity per Package

5

Contains DI Package

07350031350166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box