Catalog Number

MC-RAN-8CSTS

Brand Name

MC-RAN-8CSTS, STERILE F/G, CE

Version/Model Number

8 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

07684b2e-6732-452c-8a1a-656430ebdd74

Public Version Date

January 11, 2022

Public Version Number

1

DI Record Publish Date

January 03, 2022

Package DI Number

10850023741520

Quantity per Package

1

Contains DI Package

00850023741523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack