Catalog Number

SSUP215STR

Brand Name

Synchro SELECT

Version/Model Number

SSUP215STR

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

K202522

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

5c34ee89-b113-48cf-9446-2b47089dd6b3

Public Version Date

October 28, 2020

Public Version Number

1

DI Record Publish Date

October 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-