PASS XS

GUDID 03613720248149

Ø5.5 mm x 35 mm POLYAXIAL SCREW

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720248149
• NIH Device Record Key: fea82ab9-6011-4246-8892-3ddcc02f445b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS XS
• Version Model Number: B19115535
• 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	03613720248149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160640

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

Moist Heat or Steam Sterilization

[03613720248149]

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 XS]

• 03613720247166: CLAW COUNTER HOOK HOLDER
• 03613720248712: T HANDLE
• 03613720247104: NUT REMOVER
• 03613720246954: ROD HOLDER
• 03613720246848: SCREWDRIVER SHAFT
• 03613720248903: T20 SCREWDRIVER SHAFT, LONG
• 03613720248736: SLIM T HANDLE
• 03613720248729: PALM HANDLE
• 03613720248705: STRAIGHT HANDLE
• 03613720248699: TORQUE LIMITING HANDLE - 4 Nm
• 03613720248675: Ø4.5 mm x 450 mm ROD, CoCr
• 03613720248668: Ø4.5 mm x 440 mm ROD, CoCr
• 03613720248651: Ø4.5 mm x 420 mm ROD, CoCr
• 03613720248644: Ø4.5 mm x 400 mm ROD, CoCr
• 03613720248637: Ø4.5 mm x 380 mm ROD, CoCr
• 03613720248620: Ø4.5 mm x 360 mm ROD, CoCr
• 03613720248613: Ø4.5 mm x 340 mm ROD, CoCr
• 03613720248606: Ø4.5 mm x 320 mm ROD, CoCr
• 03613720248590: Ø4.5 mm x 300 mm ROD, CoCr r
• 03613720248583: Ø4.5 mm x 280 mm ROD, CoCr
• 03613720248576: Ø4.5 mm x 260 mm ROD, CoCr
• 03613720248569: Ø4.5 mm x 240 mm ROD, CoCr
• 03613720248552: Ø4.5 mm x 220 mm ROD, CoCr
• 03613720248545: Ø4.5 mm x 200 mm ROD, CoCr
• 03613720248538: Ø4.5 mm x 180 mm ROD, CoCr
• 03613720248521: Ø4.5 mm x 160 mm ROD, CoCr
• 03613720248514: Ø4.5 mm x 140 mm ROD, CoCr
• 03613720248507: Ø4.5 mm x 120 mm ROD, CoCr
• 03613720248491: Ø4.5 mm x 100 mm ROD, CoCr
• 03613720248484: Ø4.5 mm x 80 mm ROD, CoCr
• 03613720248477: Ø4.5 mm x 60 mm ROD, CoCr
• 03613720248460: CROSSLINK FOR Ø4.5 mm ROD, 10 mm - 37 mm
• 03613720248453: OFFSET CONNECTOR FOR Ø4.5 mm ROD
• 03613720248446: ANGULATED CONNECTOR FOR Ø4.5 mm ROD
• 03613720248439: DRC CONNECTOR FOR Ø4.5 mm ROD
• 03613720248422: STANDARD CONNECTOR FOR Ø4.5 mm ROD
• 03613720248415: BREAK AWAY NUT
• 03613720248361: Ø4.5 mm x 450 mm ROD, Ti
• 03613720248354: Ø4.5 mm x 440 mm ROD, Ti
• 03613720248347: Ø4.5 mm x 420 mm ROD, Ti
• 03613720248330: Ø4.5 mm x 400 mm ROD, Ti
• 03613720248323: Ø4.5 mm x 380 mm ROD, Ti
• 03613720248316: Ø4.5 mm x 360 mm ROD, Ti
• 03613720248309: Ø4.5 mm x 340 mm ROD, Ti
• 03613720248293: Ø4.5 mm x 320 mm ROD, Ti
• 03613720248286: Ø4.5 mm x 300 mm ROD, Ti
• 03613720248279: Ø4.5 mm x 280 mm ROD, Ti
• 03613720248262: Ø4.5 mm x 260 mm ROD, Ti
• 03613720248255: Ø4.5 mm x 240 mm ROD, Ti
• 03613720248248: Ø4.5 mm x 220 mm ROD, Ti