MReye - MReye Embolization Coil - COOK INCORPORATED

Duns Number:042823948

Device Description: MReye Embolization Coil

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More Product Details

Catalog Number

IMWCE-35-10-4

Brand Name

MReye

Version/Model Number

G42436

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

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Device Record Status

Public Device Record Key

455ed41e-03e7-4454-9dae-2280a4805404

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242