PASS TL

GUDID 03613720263531

RIGHT TP HOOK - 15 -9

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID03613720263531
NIH Device Record Key4dac75f5-d61b-49da-9400-7661f1a766e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS TL
Version Model NumberB22111509R
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720263531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


[03613720263531]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-12
Device Publish Date2017-08-08

On-Brand Devices [PASS TL]

03613720267188FINE TUNER
03613720249856REVISION SCREWDRIVER
03613720267164NUT RELEASER
03613720263357IMPACTOR LOCKER
03613720264996NUT DRIVER T25
03613720249832ROCKER FORK
03613720249740NUT DRIVER
03613720249733PEDICLE SCREWDRIVER
03613720263388PEDICLE HOOK HOLDER
03613720263371MEDIAL HOOK HOLDER
03613720263364LATERAL HOOK HOLDER
03613720263340IMPACTOR
03613720263333TAB BREAKER
03613720263326COUNTER TORQUE
03613720263708PEDICLE HOOK - 0 - 8
03613720263692PEDICLE HOOK - 0 - 6.5
03613720263685PEDICLE HOOK - 0 - 5
03613720263586LEFT TP HOOK - 15 -10
03613720263579LEFT TP HOOK - 15 -9
03613720263562LEFT TP HOOK - 15 -8
03613720263548RIGHT TP HOOK - 15 -10
03613720263531RIGHT TP HOOK - 15 -9
03613720263524RIGHT TP HOOK - 15 -8
03613720263500TP HOOK - 0 -10
03613720263494TP HOOK - 0 -9
03613720263487TP HOOK - 0 -8
03613720263470SET SCREW FOR HOOK
03613720271383HOOK INSTRUMENT INSERT
03613720270898OFFSET HEAD POSITIONER
03613720270799DUAL NUT INSERTER
03613720267461Break-Off Set Screw
03613720267171POLYAXIALITY LOCKER
03613720263449HOOK CADDY
03613720263432HOOK INSTRUMENT TRAY
03613720253990ILIAC CLOSED SCREW Ø6,5 mm x 80 mm
03613720253983ILIAC CLOSED SCREW Ø6,5 mm x 75 mm
03613720253976ILIAC CLOSED SCREW Ø6,5 mm x 70 mm
03613720252030ILIAC SCREW Ø6,5 mm x 80 mm
03613720252023ILIAC SCREW Ø6,5 mm x 75 mm
03613720252016ILIAC SCREW Ø6,5 mm x 70 mm
03613720252009ILIAC SCREW Ø6,5 mm x 65 mm
03613720250845PEDICLE SCREW Ø7,5 mm x 40 mm
03613720250821PEDICLE SCREW Ø7,5 mm x 30 mm
03613720250784PEDICLE SCREW Ø6,5 mm x 50 mm
03613720250777PEDICLE SCREW Ø6,5 mm x 45 mm
03613720250760PEDICLE SCREW Ø6,5 mm x 40 mm
03613720250753PEDICLE SCREW Ø6,5 mm x 35 mm
03613720250708PEDICLE SCREW Ø5,5 mm x 50 mm
03613720250692PEDICLE SCREW Ø5,5 mm x 45 mm
03613720250685PEDICLE SCREW Ø5,5 mm x 40 mm

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