Catalog Number

ECPMR0110GBT

Brand Name

ENCOR®

Version/Model Number

ECPMR0110GBT

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

d9342dde-0ec0-4d4e-8303-97ce04045c19

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

10801741086318

Quantity per Package

5

Contains DI Package

00801741086311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA