NAVIGATION INSTRUMENTS

GUDID 00889095717181

3.5mm Tap, CT, GI1

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00889095717181
NIH Device Record Keycdce2978-3a1c-4f41-a5e4-89e4dd6caf2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNAVIGATION INSTRUMENTS
Version Model Number682.906
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 Usefalse
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

Device Dimensions

Outer Diameter3.4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889095717181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889095717181]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-05
Device Publish Date2019-06-27

On-Brand Devices [NAVIGATION INSTRUMENTS]

00889095174038Pedicle Probe, Straight, GI1
00889095173840Pedicle Probe Thoracic, Straight, GI1
00889095173819Pedicle Probe, Straight, GI1
00889095717235Drill Bit for 4.0mm Screw, CT, GI1
00889095717228Drill Bit for 3.5mm Screw, CT, GI1
00889095717211Screwdriver, 2.5mm Hex, Self Retaining, CT, GI1
00889095717204ELLIPSE Polyaxial Screwdriver, CT, GI1
008890957171984.0mm Tap, CT, GI1
008890957171813.5mm Tap, CT, GI1
008890951741379.5mm Cannulated Tap, GI1
0088909517406910.5mm Cannulated Tap, GI1
008890951740524.0mm Tap, GI1
008890951740453.5mm Tap, GI1
008890951739708.5mm Cannulated Tap, GI1
008890951739637.5mm Cannulated Tap, GI1
008890951739566.5mm Cannulated Tap, GI1
008890951739495.5mm Cannulated Tap, GI1
008890951739325.0mm Cannulated Tap, GI1
008890951739018.5mm Tap, GI1
008890951738957.5mm Tap, GI1
008890951738886.5mm Tap, GI1
008890951738715.5mm Tap, GI1
008890951738645.0mm Tap, GI1
008890951738574.5mm Tap, GI1

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