N/A - CURETTE X0705066 STRAIGHT BAYANET 3.6MM - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: CURETTE X0705066 STRAIGHT BAYANET 3.6MM

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

X0705066

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2020

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

99580731-6bca-4d93-8030-841aa75758aa

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 11, 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