Integrity - Stent INT25026UX INTEGRITY 2.50X26UX - MEDTRONIC, INC.

Duns Number:006261481

Device Description: Stent INT25026UX INTEGRITY 2.50X26UX

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More Product Details

Catalog Number

-

Brand Name

Integrity

Version/Model Number

INT25026UX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P030009,P030009,P030009

Product Code Details

Product Code

MAF

Product Code Name

STENT, CORONARY

Device Record Status

Public Device Record Key

c6dce57e-fe76-4889-bc52-17e39d9bbbd0

Public Version Date

January 18, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2014

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