Catalog Number

-

Brand Name

Concerto Detachable Coil System

Version/Model Number

PV-14-40-3D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K090046

Product Code

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

b8dedb79-5d6a-48a4-97ed-4f72460a40b1

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-