GATEWAY

GUDID 00889095277692

4.0mm Threaded Staple, 3 Prong

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00889095277692
NIH Device Record Key33a36fc0-5600-4ace-a7a2-4373bb7ac3e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGATEWAY
Version Model Number129.607
Company DUNS139105691
Company NameGLOBUS MEDICAL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter
Lumen/Inner Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889095277692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


[00889095277692]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-10-10

On-Brand Devices [GATEWAY]

00849044036787Single Staple, 8.5mm
00849044036770Single Staple, 7.5mm
00849044036763Single Staple, 6.5mm
00849044036756Single Staple, 5.5mm
00849044036749Single Staple, 5.0mm
00849044036732GATEWAY Thoracolumbar Plate, 100mm
00849044036725GATEWAY Thoracolumbar Plate, 96mm
00849044036718GATEWAY Thoracolumbar Plate, 92mm
00849044036701GATEWAY Thoracolumbar Plate, 88mm
00849044036695GATEWAY Thoracolumbar Plate, 84mm
00849044036688GATEWAY Thoracolumbar Plate, 80mm
00849044036671GATEWAY Thoracolumbar Plate, 76mm
00849044036664GATEWAY Thoracolumbar Plate, 72mm
00849044036657GATEWAY Thoracolumbar Plate, 68mm
00849044036640GATEWAY Thoracolumbar Plate, 64mm
00849044036633GATEWAY Thoracolumbar Plate, 60mm
00849044036626GATEWAY Thoracolumbar Plate, 56mm
00849044036619GATEWAY Thoracolumbar Plate, 52mm
00849044036602GATEWAY Thoracolumbar Plate, 48mm
00849044036596GATEWAY Thoracolumbar Plate, 44mm
00849044036589GATEWAY Thoracolumbar Plate, 42mm
00849044036572GATEWAY Thoracolumbar Plate, 40mm
00849044036565GATEWAY Thoracolumbar Plate, 38mm
00849044036558GATEWAY Thoracolumbar Plate, 36mm
008890950387677.5mm Threaded Staple, 3 Prong
00889095038750GATEWAY Thoracolumbar Plate, 34mm
00889095038743GATEWAY Thoracolumbar Plate, 32mm
00889095038736GATEWAY Thoracolumbar Plate, 30mm
00889095038729GATEWAY Thoracolumbar Plate, 28mm
00889095038712GATEWAY Thoracolumbar Plate, 26mm
00889095038705GATEWAY Thoracolumbar Plate, 24mm
00889095038699GATEWAY Thoracolumbar Plate, 22mm
00889095038682GATEWAY Thoracolumbar Plate, 20mm
008890952776924.0mm Threaded Staple, 3 Prong
008890952776854.5mm Threaded Staple, 3 Prong
008890952776785.0mm Threaded Staple, 3 Prong
008890952776615.5mm Threaded Staple, 3 Prong
008890952776546.0mm Threaded Staple, 3 Prong
008890952776476.5mm Threaded Staple, 3 Prong
008890952776307.0mm Threaded Staple, 3 Prong

Trademark Results [GATEWAY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GATEWAY
GATEWAY
98760082 not registered Live/Pending
GATEWAY STUDIOS, LLC
2024-09-19
GATEWAY
GATEWAY
98219046 not registered Live/Pending
Portal Biotechnologies, Inc.
2023-10-11
GATEWAY
GATEWAY
98146328 not registered Live/Pending
Res-Care, Inc. DBA BrightSpring Health Services
2023-08-23
GATEWAY
GATEWAY
97907659 not registered Live/Pending
ZUMEDIA INC.
2023-04-26
GATEWAY
GATEWAY
97418384 not registered Live/Pending
Ortho Solutions, LC
2022-05-19
GATEWAY
GATEWAY
97085887 not registered Live/Pending
MP Group NV
2021-10-21
GATEWAY
GATEWAY
97075964 not registered Live/Pending
Acer Incorporated
2021-10-15
GATEWAY
GATEWAY
97075963 not registered Live/Pending
Acer Incorporated
2021-10-15
GATEWAY
GATEWAY
90869184 not registered Live/Pending
Mountain View Seeds LLC
2021-08-06
GATEWAY
GATEWAY
90692528 not registered Live/Pending
Gateway Business Brokers, LLC
2021-05-05
GATEWAY
GATEWAY
90659468 not registered Live/Pending
Mountain View Seeds, Ltd
2021-04-21
GATEWAY
GATEWAY
90530773 not registered Live/Pending
DNC Parks & Resorts at KSC, Inc.
2021-02-16

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