Catalog Number

-

Brand Name

Sapphire NC Plus

Version/Model Number

250-153-2U

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

K192344

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Public Device Record Key

8f347818-e4c8-4cf3-b213-7df7c422ee51

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-