MATRIX2 - 360 Ultrasoft SR Detachable Coil - Stryker Corporation

Duns Number:042405446

Device Description: 360 Ultrasoft SR Detachable Coil

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

498408-SR

Brand Name

MATRIX2

Version/Model Number

M003498408SR0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Device Record Status

Public Device Record Key

bed15ae3-8a0a-41a4-a31e-7a8d740fb7df

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86