PercuSet Basic Biopsy Tray - Basic Biopsy Tray w/o Biopsy Needle - BRACCO DIAGNOSTICS INC

Duns Number:849234661

Device Description: Basic Biopsy Tray w/o Biopsy Needle

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More Product Details

Catalog Number

600602

Brand Name

PercuSet Basic Biopsy Tray

Version/Model Number

600602

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

-

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

OJT

Product Code Name

Aspiration Tray

Device Record Status

Public Device Record Key

36854ad6-dfdc-4125-837e-24006a6e7185

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRACCO DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 28