PASS LP PASS TL

GUDID 03613720295716

HOOK B22111510R RIGHT TP 15-10

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system hook
Primary Device ID03613720295716
NIH Device Record Key710328b3-46f2-4bfc-ba20-afc5cd66432d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS LP PASS TL
Version Model NumberB22111510R
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720295716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


[03613720295716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-05
Device Publish Date2024-07-27

On-Brand Devices [PASS LP PASS TL]

03613720295631HOOK B22110008 TP 0-8
03613720295624SET SCREW B22110001 FOR HOOK
03613720295747HOOK B22120008 PEDICLE 0-8
03613720295730HOOK B22120006 PEDICLE 0-6.5
03613720295723HOOK B22120005 PEDICLE 0-5
03613720295716HOOK B22111510R RIGHT TP 15-10
03613720295709HOOK B22111510L LEFT TP 15-10
03613720295693HOOK B22111509R RIGHT TP 15-9
03613720295686HOOK B22111509L LEFT TP 15-9
03613720295679HOOK B22111508R RIGHT TP 15-8
03613720295662HOOK B22111508L LEFT TP 15-8
03613720295655HOOK B22110010 TP 0-10
03613720295648HOOK B22110009 TP 0-9

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