Catalog Number

SBS-5

Brand Name

RANFAC BREAST MRK, 5CM F/G

Version/Model Number

5CM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K845038,K845038,K845038

Product Code

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

d791cdcd-9120-4044-b8d5-06f630c6dce7

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

May 04, 2017

Package DI Number

M9796000401M9

Quantity per Package

16

Contains DI Package

M9796000401M1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case