COEfficient™ - COE140 COEFFICIENT BALLOON 5 X 4 X 135 - B BRAUN INTERVENTIONAL SYSTEMS, INC

Duns Number:784259751

Device Description: COE140 COEFFICIENT BALLOON 5 X 4 X 135

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More Product Details

Catalog Number

611235

Brand Name

COEfficient™

Version/Model Number

611235

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2020

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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

K014124

Product Code Details

Product Code

MAD

Product Code Name

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

Device Record Status

Public Device Record Key

7450b07d-65fc-49e7-8884-081b543d2ee9

Public Version Date

March 25, 2020

Public Version Number

4

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B BRAUN INTERVENTIONAL SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1226
3 A medical device with high risk that requires premarket approval 361