PASS TL

GUDID 03613720250678

PEDICLE SCREW Ø5,5 mm x 35 mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720250678
• NIH Device Record Key: e8a6706b-106d-4ae1-a39d-f372bcdb32f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS TL
• Version Model Number: B22005535
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720250678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161627

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

[03613720250678]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-23
• Device Publish Date: 2017-01-27

On-Brand Devices [PASS TL]

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