Helix - Helix Revolution Implant Tray - Nuvasive, Inc.

Duns Number:053950783

Device Description: Helix Revolution Implant Tray

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Helix

Version/Model Number

HELIXRIMP997

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

K143579

Product Code Details

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Device Record Status

Public Device Record Key

4c95bb3d-6d0e-4426-b8bf-8dc564fe001b

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

December 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUVASIVE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4207
2 A medical device with a moderate to high risk that requires special controls. 38751
3 A medical device with high risk that requires premarket approval 84
U Unclassified 29