Cook - Mini Compression Balloon Catheter with Silicone - COOK INCORPORATED

Duns Number:042823948

Device Description: Mini Compression Balloon Catheter with Silicone Balloon

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More Product Details

Catalog Number

MCB-3.0-CE-60

Brand Name

Cook

Version/Model Number

G10324

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Device Record Status

Public Device Record Key

6ae9be90-0cc8-4434-bcab-6a424e3e0305

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

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