Catalog Number

MC-RAN-11C

Brand Name

MC-RAN-11C, STERILE F/G

Version/Model Number

11 Gauge x 9CM

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

6d863b7e-e48e-45f6-9773-2cc79a3254ba

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

Package DI Number

20857878007198

Quantity per Package

10

Contains DI Package

10857878007191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case