Inrad - PreciseCore Biopsy 14 ga x 10 cm 10 mm notch - Inrad

Duns Number:940023385

Device Description: PreciseCore Biopsy 14 ga x 10 cm 10 mm notch

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More Product Details

Catalog Number

-

Brand Name

Inrad

Version/Model Number

671014

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093399,K093399

Product Code Details

Product Code

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

6ae78855-e19a-4354-ae1a-9654337ccadb

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2016

Additional Identifiers

Package DI Number

10817295020753

Quantity per Package

5

Contains DI Package

00817295020756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"INRAD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 53