ENCOR® - ENCOR® Probe Stereotactic/Ultrasound 7G - SENORX, INC.

Duns Number:043674543

Device Description: ENCOR® Probe Stereotactic/Ultrasound 7G

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More Product Details

Catalog Number

ECP017G

Brand Name

ENCOR®

Version/Model Number

ECP017G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Device Record Status

Public Device Record Key

d91cbc0f-b367-4839-a9f2-d23169152591

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10801741086288

Quantity per Package

5

Contains DI Package

00801741086281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"SENORX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65