COMPLETE SE BILIARY - STENT SC520L COMPLETE SE LONG US 3L G - MEDTRONIC, INC.

Duns Number:006261481

Device Description: STENT SC520L COMPLETE SE LONG US 3L G

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More Product Details

Catalog Number

-

Brand Name

COMPLETE SE BILIARY

Version/Model Number

SC520L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2018

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

K062264

Product Code Details

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

d81ec9de-922e-4b2b-9686-1ab1ea2e5ad0

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

June 08, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601