N/A - CURRETTE 9150053 8 X 14MM - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: CURRETTE 9150053 8 X 14MM

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9150053

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2018

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

-

Product Code Details

Product Code

HTF

Product Code Name

CURETTE

Device Record Status

Public Device Record Key

0913b209-1be8-4fcc-89f4-d78cb672c982

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75