Helix

GUDID 00887517519009

Helix Revolution Plate Holding DTS Set

Nuvasive, Inc.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00887517519009
NIH Device Record Keye30a4d24-0d82-40af-a8a0-6588f1a235e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHelix
Version Model NumberHELIXRDTS
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517519009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


[00887517519009]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-10
Device Publish Date2016-09-23

On-Brand Devices [Helix]

00887517519122Helix Mini Plate Set
00887517519108Helix-T Pos Eng DTS Guides Set
00887517519092Helix Family Self-Centering Tack Set
00887517519061Helix Translational Set
00887517519009Helix Revolution Plate Holding DTS Set
00887517518996Helix-R Positive Engagement Driver Sets
00887517518972Helix Revolution
00887517518958Helix Revolution Set
00887517518903Helix ACP Set
00887517327475Helix Screwdriver, NV9
00887517319166Helix ACP Tap, 13mm
00887517319142Single Drill Guide
00887517149251Helix-R Drill Bit, 2.5x10mm Power
00887517144416Helix-R Template, 95mm 5-Level
00887517144409Helix-R Template, 90mm 5-Level
00887517143990Helix-R Template, 110mm 5-Level
00887517143983Helix-R Template, 105mm 5-Level
00887517143976Helix-R Template, 100mm 5-Level
00887517141873Helix-R Tack, Temporary
00887517141330Helix R Screw, 4.5x19mm Fixed Self-Tap
00887517141323Helix R Screw, 4.5x17mm Fixed Self-Tap
00887517141316Helix R Screw, 4.5x15mm Fixed Self-Tap
00887517141309Helix R Screw, 4.5x13mm Fixed Self-Tap
00887517140890Helix R Screw, 4.5x11mm Fixed Self-Tap
00887517140333Helix R Screw, 4.5x19mm Var Self-Tap
00887517140326Helix R Screw, 4.5x17mm Var Self-Tap
00887517140319Helix R Screw, 4.5x15mm Var Self-Tap
00887517140302Helix R Screw, 4.5x14mm Self-Tap Var
00887517139696Helix R Screw, 4.5x13mm Var Self-Tap
00887517139689Helix R Screw, 4.5x11mm Var Self-Tap
00887517139672Helix R Screw, 4x19mm Fixed Self-Tap
00887517139665Helix R Screw, 4x17mm Fixed Self-Tap
00887517139658Helix R Screw, 4x15mm Fixed Self-Tap
00887517139641Helix R Screw, 4x13mm Fixed Self-Tap
00887517139634Helix R Screw, 4x11mm Fixed Self-Tap
00887517138965Helix R Screw, 4x19mm Var Self-Tap
00887517138958Helix R Screw, 4x17mm Var Self-Tap
00887517138941Helix R Screw, 4.0x16mm Self-Tap Var
00887517138934Helix R Screw, 4x15mm Var Self-Tap
00887517138927Helix R Screw, 4.0x14mm Self-Tap Var
00887517138910Helix R Screw, 4x13mm Var Self-Tap
00887517138903Helix R Screw, 4.0x12mm Self-Tap Var
00887517138491Helix R Screw, 4x11mm Var Self-Tap
00887517138484Helix R Screw, 4x10mm Var Self-Tap
00887517138477Helix R Screw, 4x15mm Fixed Self-Drill
00887517138460Helix R Screw, 4x13mm Fixed Self-Drill
00887517138453Helix R Screw, 4x11mm Fixed Self-Drill
00887517137982Helix R Screw, 4x19mm Var Self-Drill
00887517137968Helix R Screw, 4x17mm Var Self-Drill
00887517137951Helix R Screw, 4x16mm Var Self-Drill

Trademark Results [Helix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELIX
HELIX
98379822 not registered Live/Pending
Austin Powder Company
2024-01-29
HELIX
HELIX
98366356 not registered Live/Pending
Slingmax, LLC
2024-01-19
HELIX
HELIX
98347308 not registered Live/Pending
TrueProp Software, LLC
2024-01-08
HELIX
HELIX
98344243 not registered Live/Pending
LSC Environmental Products, LLC
2024-01-05
HELIX
HELIX
98221746 not registered Live/Pending
Polar Pro Filters, Inc.
2023-10-12
HELIX
HELIX
98204626 not registered Live/Pending
Verkada Inc.
2023-09-29
HELIX
HELIX
98157700 not registered Live/Pending
Opener LLC
2023-08-30
HELIX
HELIX
98016261 not registered Live/Pending
Selkirk Sport, LLC
2023-05-26
HELIX
HELIX
97930519 not registered Live/Pending
Konscious Keto LLC
2023-05-10
HELIX
HELIX
97930128 not registered Live/Pending
Konscious Keto LLC
2023-05-10
HELIX
HELIX
97838756 not registered Live/Pending
Onikoroshi, LLC
2023-03-14
HELIX
HELIX
97838459 not registered Live/Pending
Forest River, Inc.
2023-03-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.