NA - STYLET 609397 STRT EXTD TPR GLBL EIFU - MEDTRONIC, INC.

Duns Number:006261481

Device Description: STYLET 609397 STRT EXTD TPR GLBL EIFU

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

609397

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

DRB

Product Code Name

STYLET, CATHETER

Device Record Status

Public Device Record Key

6696131e-3bf5-4198-9af9-b7a3424cac72

Public Version Date

September 19, 2018

Public Version Number

1

DI Record Publish Date

August 19, 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