SAVANNAH - SAVANNAH® N DRIVER INNER SHAFT - SPINAL ELEMENTS

Duns Number:004022104

Device Description: SAVANNAH® N DRIVER INNER SHAFT

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More Product Details

Catalog Number

-

Brand Name

SAVANNAH

Version/Model Number

11000-154-01

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)

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

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Device Record Status

Public Device Record Key

445d4df4-9b83-4395-b66b-8008b16bcafc

Public Version Date

December 10, 2021

Public Version Number

2

DI Record Publish Date

January 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1993
2 A medical device with a moderate to high risk that requires special controls. 3642
U Unclassified 15