Catalog Number

-

Brand Name

SCP

Version/Model Number

614.584

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"

-

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

-

Product Code

-

Product Code Name

-

Public Device Record Key

a48ca7ca-3c40-4cfa-bf54-da34db8b7c6e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2015

Package DI Number

00889024406650

Quantity per Package

4

Contains DI Package

00889024406681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-