Sprinter™ - BALLOON SPR4012W SPRINTER OTW 4.0X12MM - MEDTRONIC, INC.

Duns Number:006261481

Device Description: BALLOON SPR4012W SPRINTER OTW 4.0X12MM

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More Product Details

Catalog Number

-

Brand Name

Sprinter™

Version/Model Number

SPR4012W

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

P790017

Product Code Details

Product Code

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Device Record Status

Public Device Record Key

69132676-9de8-4c26-b998-1fce0f0c2343

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

January 14, 2018

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