HydroMark - HydroMARK Breast Biopsy Site Marker - DEVICOR MEDICAL PRODUCTS, INC.

Duns Number:961832156

Device Description: HydroMARK Breast Biopsy Site Marker

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More Product Details

Catalog Number

-

Brand Name

HydroMark

Version/Model Number

4010-01-11-T3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K121113,K121113

Product Code Details

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Device Record Status

Public Device Record Key

889a0a31-aa81-4cbf-be2e-734cc76aee76

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 25, 2016

Additional Identifiers

Package DI Number

10841911101434

Quantity per Package

10

Contains DI Package

00841911101437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DEVICOR MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 186