NA - CONNECTOR 1393 HANSEN QUICK 90' ANGLE - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CONNECTOR 1393 HANSEN QUICK 90' ANGLE

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

1393

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K894980

Product Code Details

Product Code

DWJ

Product Code Name

SYSTEM, THERMAL REGULATING

Device Record Status

Public Device Record Key

b5462178-eff8-4877-be7e-2274d0b89759

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 02, 2016

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