Catalog Number

20115008

Brand Name

SQUARE BROACH

Version/Model Number

n10 L29

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"

-

For Single-Use

-

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

-

Product Code

EKB

Product Code Name

Explorer, Operative

Public Device Record Key

25541963-4718-432a-9c25-11213b354a5c

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Package DI Number

J015201150089

Quantity per Package

12

Contains DI Package

J015201150081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box