PASS MIS

GUDID 03613720190462

PRE-BENT ROD Ø 6mm x 100mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720190462
• NIH Device Record Key: 6519f031-13ad-4321-b876-f2ba7ac5cd93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS MIS
• Version Model Number: B06034100
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• 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	03613720190462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112493

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

Moist Heat or Steam Sterilization

[03613720190462]

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: 2015-10-23

On-Brand Devices [PASS MIS]

• 03613720213536: STRAIGHT ROD HOLDER
• 03613720213529: CURVED ROD HOLDER
• 03613720213499: MIS CONNECTOR HOLDER
• 03613720213475: INITIAL CONNECTOR HOLDER LEFT
• 03613720213468: INITIAL CONNECTOR HOLDER RIGHT
• 03613720190868: PRE-BENT MIS ROD Ø 5.5mm x 40mm
• 03613720210290: O-BATCH MEDICREA CASE
• 03613720274056: BLUNT K-WIRE - Ø1.6 mm x 500 mm - NITINOL
• 03613720274049: TROCAR K-WIRE - Ø1.6 mm x 500 mm - NITINOL
• 03613720213802: PASS MIS - TRAY 4
• 03613720213796: PASS MIS - TRAY 3
• 03613720213789: PASS MIS - TRAY 2
• 03613720213772: PASS MIS - TRAY 1
• 03613720213765: PASS MIS O-BATCH CASE N°2
• 03613720213758: PASS MIS O-BATCH CASE N°1
• 03613720213673: COUNTER TORQUE
• 03613720213598: CANNULATED SCREWDRIVER
• 03613720213581: NUT STARTER SHAFT
• 03613720213574: NUT STARTER FOR 1/4 POWERED DRILL DEVICE
• 03613720213567: NUT DRIVER
• 03613720213437: CANNULATED TAP Ø 7.5mm
• 03613720213420: CANNULATED TAP Ø 6.5mm
• 03613720213413: CANNULATED TAP Ø 5.5mm
• 03613720213406: CANNULATED TAP Ø 5mm
• 03613720213390: PEDICLE PROBE
• 03613720210412: LID FOR INSTRUMENT TRAY
• 03613720210382: 8 COMPARTMENTS CADDY
• 03613720210375: 3 COMPARTMENTS CADDY
• 03613720210320: O-BATCH ROD TRAY
• 03613720210313: O-BATCH INSTRUMENTS TRAY
• 03613720189428: SHORT STANDARD CONNECTOR FOR Ø 6mm ROD
• 03613720189237: SHORT INITIAL CONNECTOR FOR Ø 5.5mm ROD
• 03613720227212: CANULATED MONOAXIAL PEDICLE SCREW Ø5,5 x 50 mm
• 03613720227205: CANULATED MONOAXIAL PEDICLE SCREW Ø5 x 50 mm
• 03613720213703: ANTENNA FOR COMPRESSION DISTRACTION PLIERS
• 03613720213697: COMPRESSION DISTRACTION PLIERS
• 03613720213659: COMPRESSION / DISTRACTION INSTRUMENT
• 03613720213642: ROD GAUGE
• 03613720213635: PRE-BENT ROD GAUGE
• 03613720213628: T HANDLE FOR NUT DRIVER
• 03613720213611: STRAIGHT HANDLE FOR NUT DRIVER
• 03613720213604: SPEED DRIVER MIS
• 03613720213543: ROTATION EXTENSION BREAKER
• 03613720213512: STRAIGHT ROD HOLDER
• 03613720213505: CURVED ROD HOLDER
• 03613720213482: CONNECTOR RETRIEVER
• 03613720213451: CONNECTOR HOLDER
• 03613720213383: DILATOR BLADE FOR ROD HOLDER
• 03613720213376: DILATOR BLADE
• 03613720213369: ROUND HANDLE FOR DILATOR