PASS LP

GUDID 03613720184379

MONOAXIAL PEDICLE SCREW Ø 6.5mm x 25mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 03613720184379
• NIH Device Record Key: 2ff1a01f-a234-4eb9-9d58-cf7b22c90a60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS LP
• Version Model Number: B02296525S
• 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	03613720184379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141398

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-08
• Device Publish Date: 2015-10-23

On-Brand Devices [PASS LP]

• 03613720276043: TRAUMA Ø6 mm PRE-BENT RODS - 50 TK
• 03613720276036: TRAUMA Ø6 mm PRE-BENT RODS - 26 TK
• 03613720245742: PEDICLE SCREWDRIVER FOR RETRIEVAL
• 03613720245735: CANNULATED SCREWDRIVER SHAFT
• 03613720240846: SPEEDRIVER WITH T-HANDLE
• 03613720224839: FLEXIBLE NUTDRIVER FOR CLAW
• 03613720224761: HOOK HOLDER
• 03613720224754: HOOK INSERTER SET
• 03613720224068: ROD HOLDER
• 03613720224006: NUTDRIVER AND POSITIONNER FOR PLATE AND ROD
• 03613720223993: SCREWDRIVER T20
• 03613720223986: SELFHOLDING NUTDRIVER & BREAKER
• 03613720223979: HEX HOLLOW SCREW AND NUT DRIVER 10mm
• 03613720223894: HEXAGONAL SCREWDRIVER FOR SIMPLE SCREWS 3.5mm
• 03613720223887: HEX HOLLOW SCREWDRIVER FOR MONOAXIAL SCREWS 6mm
• 03613720212287: SACRAL PLATE HOLDER
• 03613720212270: BAND HOOK HOLDER
• 03613720212263: LIGAMENT HOOK HOLDER
• 03613720212249: SCREWDRIVER FOR HOOK HEAD
• 03613720212225: COUNTER HOOK HOLDER
• 03613720212218: HOOK POST HOLDER
• 03613720212126: NUTDRIVER SHAFT FOR DISMANTLING
• 03613720212119: HEXAGONAL NUTDRIVER SHAFT
• 03613720212089: ILIAC LINK HOLDER
• 03613720212034: SPEED DRIVER
• 03613720212003: T30 SCREWDRIVER SHAFT
• 03613720211983: NUT HOLDER AND THREADED EXTENSION BREAKER
• 03613720211846: PEDICLE SCREWDRIVER SHAFT FOR SHORT POST SCREW
• 03613720211839: BASIC PEDICLE SCREWDRIVER
• 03613720211822: PEDICLE SCREWDRIVER SHAFT FOR 1/4 POWERED DRILL DEVICE
• 03613720211471: OPEN CONNECTOR HOLDER
• 03613720211440: PARS HOOK HOLDER
• 03613720211426: SACRAL SCREW HOLDER FOR T20 SCREWDRIVER
• 03613720211402: SACRAL PLATE HOLDER
• 03613720211365: NUTDRIVER SHAFT
• 03613720211358: NUTDRIVER SHAFT FOR FINAL TIGHTENING
• 03613720211341: NUTDRIVER SHAFT
• 03613720211334: NUTDRIVER
• 03613720211327: NUTDRIVER FOR POSITIONING HANDLE
• 03613720211303: NUT HOLDER
• 03613720211105: ROD HOLDER
• 03613720211037: PASS 2 SCREWDRIVER FOR REVISION
• 03613720211020: PEDICLE SCREWDRIVER SHAFT
• 03613720210788: HEX HOLLOW NUTDRIVER 8mm
• 03613720210771: HEX HOLLOW SCREWDRIVER FOR CROSSLINK SYSTEM 8mm
• 03613720210757: T20 SCREWDRIVER SHAFT
• 03613720210740: NUT DRIVER SHAFT FOR FINAL TIGHTENING
• 03613720210726: 3.5mm HEXAGONAL SCREWDRIVER SHAFT
• 03613720210634: PASSMED PEDICLE SCREWDRIVER FOR REVISION
• 03613720210627: PEDICLE SCREWDRIVER SHAFT