Catalog Number

ECPMR017G

Brand Name

ENCOR®

Version/Model Number

ECPMR017G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

11030b9e-a1ba-4fdb-b252-bf5da68ae979

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10801741086325

Quantity per Package

5

Contains DI Package

00801741086328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA