QUICK-CORE BIOPSY QC-16-9.0-10T - Izi Medical Products, LLC

Duns Number:933506164

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More Product Details

Catalog Number

-

Brand Name

QUICK-CORE BIOPSY QC-16-9.0-10T

Version/Model Number

G28282

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K973565

Product Code Details

Product Code

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

e0890c7a-9210-49e1-93e7-1ce6ad27e81d

Public Version Date

June 02, 2021

Public Version Number

1

DI Record Publish Date

May 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IZI MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 518