Catalog Number

ECP017GV

Brand Name

ENCOR®

Version/Model Number

ECP017GV

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

K051158,K051158

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

8dddff75-7ab4-4420-aae1-2f6f66e969cd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10801741086295

Quantity per Package

5

Contains DI Package

00801741086298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA