Helix
GUDID 00887517987051
Helix Revolution Instrument Tray
Nuvasive, Inc.
Sterilization/disinfection container| Primary Device ID | 00887517987051 |
| NIH Device Record Key | 1c785d28-2b76-4edc-8260-4c3a497bb719 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helix |
| Version Model Number | HELIXRINS997 |
| Company DUNS | 053950783 |
| Company Name | Nuvasive, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517987051 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143579
FDA Product Code
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
[00887517987051]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2018-12-31 |
On-Brand Devices [Helix]
| 00887517519122 | Helix Mini Plate Set |
| 00887517519108 | Helix-T Pos Eng DTS Guides Set |
| 00887517519092 | Helix Family Self-Centering Tack Set |
| 00887517519061 | Helix Translational Set |
| 00887517519009 | Helix Revolution Plate Holding DTS Set |
| 00887517518996 | Helix-R Positive Engagement Driver Sets |
| 00887517518972 | Helix Revolution |
| 00887517518958 | Helix Revolution Set |
| 00887517518903 | Helix ACP Set |
| 00887517327475 | Helix Screwdriver, NV9 |
| 00887517319166 | Helix ACP Tap, 13mm |
| 00887517319142 | Single Drill Guide |
| 00887517149251 | Helix-R Drill Bit, 2.5x10mm Power |
| 00887517144416 | Helix-R Template, 95mm 5-Level |
| 00887517144409 | Helix-R Template, 90mm 5-Level |
| 00887517143990 | Helix-R Template, 110mm 5-Level |
| 00887517143983 | Helix-R Template, 105mm 5-Level |
| 00887517143976 | Helix-R Template, 100mm 5-Level |
| 00887517141873 | Helix-R Tack, Temporary |
| 00887517141330 | Helix R Screw, 4.5x19mm Fixed Self-Tap |
| 00887517141323 | Helix R Screw, 4.5x17mm Fixed Self-Tap |
| 00887517141316 | Helix R Screw, 4.5x15mm Fixed Self-Tap |
| 00887517141309 | Helix R Screw, 4.5x13mm Fixed Self-Tap |
| 00887517140890 | Helix R Screw, 4.5x11mm Fixed Self-Tap |
| 00887517140333 | Helix R Screw, 4.5x19mm Var Self-Tap |
| 00887517140326 | Helix R Screw, 4.5x17mm Var Self-Tap |
| 00887517140319 | Helix R Screw, 4.5x15mm Var Self-Tap |
| 00887517140302 | Helix R Screw, 4.5x14mm Self-Tap Var |
| 00887517139696 | Helix R Screw, 4.5x13mm Var Self-Tap |
| 00887517139689 | Helix R Screw, 4.5x11mm Var Self-Tap |
| 00887517139672 | Helix R Screw, 4x19mm Fixed Self-Tap |
| 00887517139665 | Helix R Screw, 4x17mm Fixed Self-Tap |
| 00887517139658 | Helix R Screw, 4x15mm Fixed Self-Tap |
| 00887517139641 | Helix R Screw, 4x13mm Fixed Self-Tap |
| 00887517139634 | Helix R Screw, 4x11mm Fixed Self-Tap |
| 00887517138965 | Helix R Screw, 4x19mm Var Self-Tap |
| 00887517138958 | Helix R Screw, 4x17mm Var Self-Tap |
| 00887517138941 | Helix R Screw, 4.0x16mm Self-Tap Var |
| 00887517138934 | Helix R Screw, 4x15mm Var Self-Tap |
| 00887517138927 | Helix R Screw, 4.0x14mm Self-Tap Var |
| 00887517138910 | Helix R Screw, 4x13mm Var Self-Tap |
| 00887517138903 | Helix R Screw, 4.0x12mm Self-Tap Var |
| 00887517138491 | Helix R Screw, 4x11mm Var Self-Tap |
| 00887517138484 | Helix R Screw, 4x10mm Var Self-Tap |
| 00887517138477 | Helix R Screw, 4x15mm Fixed Self-Drill |
| 00887517138460 | Helix R Screw, 4x13mm Fixed Self-Drill |
| 00887517138453 | Helix R Screw, 4x11mm Fixed Self-Drill |
| 00887517137982 | Helix R Screw, 4x19mm Var Self-Drill |
| 00887517137968 | Helix R Screw, 4x17mm Var Self-Drill |
| 00887517137951 | Helix R Screw, 4x16mm Var Self-Drill |
Trademark Results [Helix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELIX 98853091 not registered Live/Pending |
BMC Software, Inc. 2024-11-14 |
 HELIX 98846843 not registered Live/Pending |
Onikoroshi, LLC 2024-11-11 |
 HELIX 98824753 not registered Live/Pending |
Ping Identity Corporation 2024-10-28 |
 HELIX 98679446 not registered Live/Pending |
Helix, Inc. 2024-08-02 |
 HELIX 98604665 not registered Live/Pending |
Dexter Axle Company LLC 2024-06-17 |
 HELIX 98604604 not registered Live/Pending |
Dexter Axle Company LLC 2024-06-17 |
 HELIX 98379822 not registered Live/Pending |
Austin Powder Company 2024-01-29 |
 HELIX 98366356 not registered Live/Pending |
Slingmax, LLC 2024-01-19 |
 HELIX 98347308 not registered Live/Pending |
TrueProp Software, LLC 2024-01-08 |
 HELIX 98344243 not registered Live/Pending |
LSC Environmental Products, LLC 2024-01-05 |
 HELIX 98221746 not registered Live/Pending |
Polar Pro Filters, Inc. 2023-10-12 |
 HELIX 98204626 not registered Live/Pending |
Verkada Inc. 2023-09-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.