STEALTH™ Anterior Cervical Interbody Spacer - STEALTH,SPACER,12X14X11,6 DEG - Choice Spine, LP

Duns Number:078293017

Device Description: STEALTH,SPACER,12X14X11,6 DEG

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More Product Details

Catalog Number

-

Brand Name

STEALTH™ Anterior Cervical Interbody Spacer

Version/Model Number

DP10-1214611

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)

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

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Device Record Status

Public Device Record Key

3f7a8c91-c7a3-422b-8feb-c7d677b3d480

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHOICE SPINE, LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2373
2 A medical device with a moderate to high risk that requires special controls. 5754
U Unclassified 61