UltraClip® II Breast Tissue Marker - ULTRACLIP® II wing breast tissue marker 17g x - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: ULTRACLIP® II wing breast tissue marker 17g x 10cm needle, wing clip

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More Product Details

Catalog Number

862017

Brand Name

UltraClip® II Breast Tissue Marker

Version/Model Number

862017

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

-

Product Code Details

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Device Record Status

Public Device Record Key

9a58d3c4-a294-4999-9f43-229c78a12691

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 25, 2015

Additional Identifiers

Package DI Number

10801741032285

Quantity per Package

5

Contains DI Package

00801741032288

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