PASS LP PASS TULIP

GUDID 03613720294955

PLATE B02250060L SACROILAC PLATE RIGHT

MEDICREA INTERNATIONAL

Spinal fixation plate, non-bioabsorbable
Primary Device ID03613720294955
NIH Device Record Key9897fc49-b0c2-452e-afe2-bf5cb46f754e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS LP PASS TULIP
Version Model NumberB02250060L
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
GS103613720294955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


[03613720294955]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-01
Device Publish Date2024-07-24

On-Brand Devices [PASS LP PASS TULIP]

03613720295617CONNECTOR B22066212 OP/OP DOMINO 12MM
03613720294962PLATE B02250060R SACROILAC PLATE LEFT
03613720294955PLATE B02250060L SACROILAC PLATE RIGHT

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