SenoMark® Ultra Breast Tissue Marker - SENOMARK® ULTRA Breast Tissue Marker, 12 Ga ATEC, - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: SENOMARK® ULTRA Breast Tissue Marker, 12 Ga ATEC, Titanium Ribbon

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More Product Details

Catalog Number

SMAT12R

Brand Name

SenoMark® Ultra Breast Tissue Marker

Version/Model Number

SMAT12R

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"

Yes

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

K123911,K123911

Product Code Details

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Record Status

Public Device Record Key

5924ddc9-9069-40a8-8d4e-9440844360b4

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 01, 2015

Additional Identifiers

Package DI Number

10801741032117

Quantity per Package

10

Contains DI Package

00801741032110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"BARD PERIPHERAL VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 2835
3 A medical device with high risk that requires premarket approval 190