PASS LP SPINAL SYSTEM

GUDID 03613720294122

ROD B02176006 PRE BENT 6.0X60MM TI NS

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system rod
Primary Device ID03613720294122
NIH Device Record Keybd2d1cfe-d627-4808-b0a0-cd66c51a341a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS LP SPINAL SYSTEM
Version Model NumberB02176006
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
GS103613720294122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

Moist Heat or Steam Sterilization

[03613720294122]

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 SPINAL SYSTEM]

03613720295532CONNECTOR B06020860 SHRT STD FOR 6MM ROD
03613720295525CONNECTOR B06020455 SHORT INITIAL 5.5MM
03613720295518SCREW B02518560 DUAL LEAD 8.5X60MM
03613720295501SCREW B02518555 DUAL LEAD 8.5X55MM
03613720295495SCREW B02518550 DUAL LEAD 8.5X50MM
03613720295488SCREW B02518545 DUAL LEAD 8.5X45MM
03613720295471SCREW B02518540 DUAL LEAD 8.5X40MM
03613720295464SCREW B02518535 DUAL LEAD 8.5X35MM
03613720295457SCREW B02518530 DUAL LEAD 8.5X30MM
03613720295440SCREW B02517560 DUAL LEAD 7.5X60MM
03613720295433SCREW B02517555 DUAL LEAD 7.5X55MM
03613720295426SCREW B02517550 DUAL LEAD 7.5X50MM
03613720295419SCREW B02517545 DUAL LEAD 7.5X45MM
03613720295402SCREW B02517540 DUAL LEAD 7.5X40MM
03613720295396SCREW B02517535 DUAL LEAD 7.5X35MM
03613720295389SCREW B02517530 DUAL LEAD 7.5X30MM
03613720295372SCREW B02516560 DUAL LEAD 6.5X60MM
03613720295365SCREW B02516555 DUAL LEAD 6.5X55MM
03613720295358SCREW B02516550 DUAL LEAD 6.5X50MM
03613720295341SCREW B02516545 DUAL LEAD 6.5X45MM
03613720295334SCREW B02516540 DUAL LEAD 6.5X40MM
03613720295327SCREW B02516535 DUAL LEAD 6.5X35MM
03613720295310SCREW B02516530 DUAL LEAD 6.5X30MM
03613720295303SCREW B02515555 DUAL LEAD 5.5X55MM
03613720295297SCREW B02515550 DUAL LEAD 5.5X50MM
03613720295280SCREW B02515545 DUAL LEAD 5.5X45MM
03613720295273SCREW B02515540 DUAL LEAD 5.5X40MM
03613720295266SCREW B02515535 DUAL LEAD 5.5X35MM
03613720295259SCREW B02515530 DUAL LEAD 5.5X30MM
03613720295242SCREW B02515525 DUAL LEAD 5.5X25MM
03613720295235SCREW B02515055 PEDICLE 5.0X55MM
03613720295228SCREW B02515045 PEDICLE 5.0X45MM
03613720295211SCREW B02515040 PEDICLE 5.0X40MM
03613720295204SCREW B02515035 PEDICLE 5.0X35MM
03613720295198SCREW B02515030 PEDICLE 5.0X30MM
03613720295181SCREW B02515025 PEDICLE 5.0X25MM
03613720295174SCREW B02514545 DUAL LEAD 4.5X45MM
03613720295167SCREW B02514540 DUAL LEAD 4.5X40MM
03613720295150SCREW B02514535 DUAL LEAD 4.5X35MM
03613720295143SCREW B02514530 DUAL LEAD 4.5X30MM
03613720295136SCREW B02514525 DUAL LEAD 4.5X25MM
03613720295129SCREW B02416545 CANNULA DUAL 6.5X45MM
03613720295112SCREW B02416535 CANNULA DUAL 6.5X35MM
03613720295105CROSSLINK B02366010 UPSIDE DOWN 6MM S
03613720295099CONNECTOR B02336087 LEFT AXIAL SHORT
03613720295082CONNECTOR B02336086 RIGHT AXIAL SHORT
03613720295075CONNECTOR B02336080 AXIAL SHORT
03613720295068CONNECTOR B02286010 ILIAC LINK 6MM ROD
03613720295051CROSSLINK B02266020 6.0MM ROD MEDIUM
03613720295044CROSSLINK B02266010 6.0MM ROD SMALL
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.