XULTAN CROSSLINK DRIVER REMOVAL TOOL 30290348

GUDID 00819824023757

THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.

MET 1 TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID00819824023757
NIH Device Record Keyf7535a4e-37ee-4fba-bbcc-6b2509666712
Commercial Distribution StatusIn Commercial Distribution
Brand NameXULTAN CROSSLINK DRIVER REMOVAL TOOL
Version Model Number30290348
Catalog Number30290348
Company DUNS080474650
Company NameMET 1 TECHNOLOGIES, LLC
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 Batchfalse
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

Phone9154726762
Emailyone@met1tech.com
Phone9154726762
Emailyone@met1tech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819824023757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819824023757]

Moist Heat or Steam Sterilization


[00819824023757]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-29

On-Brand Devices [XULTAN CROSSLINK DRIVER REMOVAL TOOL]

00819824023894THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE
00819824023757THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE

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