STAINLESS STEEL TIBIAL NAILING SYSTEM 155025

GUDID 18053504364733

Component. Not for sale. Used for reporting Direct Marking of assembly.

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18053504364733
• NIH Device Record Key: c3083f3d-1e55-430a-921d-67f62c079594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAINLESS STEEL TIBIAL NAILING SYSTEM
• Version Model Number: 1
• Catalog Number: 155025
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504364733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18053504364733]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [STAINLESS STEEL TIBIAL NAILING SYSTEM]

• 18053504361794: DRILL BIT L280MM D4MM STERILE
• 18033509851230: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 90 MM
• 18033509851223: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 85 MM
• 18033509851216: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 80 MM
• 18033509851209: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 75 MM
• 18033509851193: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 70 MM
• 18033509851186: REVISION LOCKING SCREW REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 65 MM
• 18033509851179: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 60 MM
• 18033509851162: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 55 MM
• 18033509851155: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 50 MM
• 18033509851148: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 45 MM
• 18033509851131: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 40 MM
• 18033509851124: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 35 MM
• 18033509851117: REVISION LOCKING SCREW STERILE THREAD D 8 MM LENGTH 30 MM
• 18033509851070: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 75 MM
• 18033509851063: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 70 MM
• 18033509851056: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 65 MM
• 18033509851049: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 60 MM
• 18033509851032: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 55 MM
• 18033509851025: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 50 MM
• 18033509851018: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 45 MM
• 18033509851001: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 40 MM
• 18033509850998: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 35 MM
• 18033509850981: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 30 MM
• 18033509850974: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 25 MM
• 18033509850967: TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM LENGTH 20 MM
• 18033509850950: REVISION LOCKING SCREW WASHER STERILE
• 18032937169627: CALIBRATED DRILL BIT D.4 MM L.180 MM TIN COATED - QUICK CONNECT
• 18032568869248: ISKD TIBIAL GUIDE BAR
• 18032568867688: CALIBRATED DRILL BIT D. 4.0 MM L. 180 MM
• 18032568867657: DRILL GUIDE D. 8.0/4.8 MM L. 156 MM
• 18032568867329: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 350 MM
• 18032568867312: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 330 MM
• 18032568864830: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 400 MM
• 18032568864823: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 380 MM
• 18032568864816: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 360 MM
• 18032568864809: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 340 MM
• 18032568864793: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 320 MM
• 18032568864786: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 300 MM
• 18032568864779: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 280 MM
• 18032568864762: CANNULATED TIBIAL NAIL - SHORT DIAMETER 10 MM LENGTH 260 MM
• 18032568864755: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 400 MM
• 18032568864748: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 400 MM
• 18032568864731: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 380 MM
• 18032568864724: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 360 MM
• 18032568864717: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 350 MM
• 18032568864700: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 340 MM
• 18032568864694: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 330 MM
• 18032568864687: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 320 MM
• 18032568864670: SOLID TIBIAL NAIL - SHORT DIAMETER 9 MM LENGTH 300 MM