Catalog Number

-

Brand Name

QC-20-6.0-20T

Version/Model Number

G28124

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

c31aa038-351f-4eeb-b705-4e9f53e58d2a

Public Version Date

October 28, 2021

Public Version Number

1

DI Record Publish Date

October 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-