MEDADV - ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 18 mm - MEDAS INC

Duns Number:080593067

Device Description: ENCOURAGE PTCA BALLOON CATHETER 1.5 mm X 18 mm RAPID EXCHANGE

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More Product Details

Catalog Number

M29115018

Brand Name

MEDADV

Version/Model Number

M92115018

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"

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

K123473

Product Code Details

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device Record Status

Public Device Record Key

9ce4845f-8c61-46c5-9361-84f6636db152

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

April 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDAS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 40