N/A - PROBE 9450015 NIM BALL TIP 23CM - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: PROBE 9450015 NIM BALL TIP 23CM

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

9450015

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031003

Product Code Details

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Device Record Status

Public Device Record Key

ba60f5bc-bd26-4f60-a34d-ce95fa6a8f52

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 17, 2016

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