Catalog Number

9471-VC-006

Brand Name

ONCONTROL

Version/Model Number

IPN919033

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

b9046840-bd90-4a1a-8386-423b489dd384

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 21, 2022

Package DI Number

20841156108646

Quantity per Package

6

Contains DI Package

10841156108649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case