Catalog Number

MC-RAN-11CSTS

Brand Name

MC-RAN-11CSTS, STERILE F/G

Version/Model Number

11 Gauge X 11CM

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"

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

K150563,K150563,K150563

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

ab6cc8e5-a066-4652-9eef-5aa2e7258867

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 06, 2017

Package DI Number

20858690006086

Quantity per Package

30

Contains DI Package

10858690006089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case