TRUELOK 450500-689C

GUDID 18052469476376

TRUELOK RING TRAY SET - 160-180-200MM COMPLETE

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18052469476376
• NIH Device Record Key: f0ca8a10-5511-47c6-a2f6-6a25f2069472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUELOK
• Version Model Number: 1
• Catalog Number: 450500-689C
• 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: true
• 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: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it
• Phone: 0456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052469476376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941048

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Sterilization

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

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

[18052469476376]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [TRUELOK]

• 18053340349529: TL+ FOOTPLATE 100MM STERILE
• 18053340349512: TL PLUS FIVE EIGHTHS RING 200MM STERILE
• 18053340349505: TL PLUS FIVE EIGHTHS RING 180MM STERILE
• 18053340349499: TL PLUS FIVE EIGHTHS RING 170MM STERILE
• 18053340349482: TL PLUS FIVE EIGHTHS RING 160MM STERILE
• 18053340349475: TL PLUS FIVE EIGHTHS RING 150MM STERILE
• 18053340349468: TL PLUS FIVE EIGHTHS RING 140MM STERILE
• 18053340349451: TL PLUS FIVE EIGHTHS RING 130MM STERILE
• 18053340349444: TL PLUS FIVE EIGHTHS RING 120MM STERILE
• 18053340349437: TL PLUS FIVE EIGHTHS RING 100MM STERILE
• 18053340349420: TL PLUS HALF RING 240MM STERILE
• 18053340349413: TL PLUS HALF RING 220MM STERILE
• 18053340349406: TL PLUS HALF RING 200MM STERILE
• 18053340349390: TL PLUS HALF RING 180MM STERILE
• 18053340349383: TL PLUS HALF RING 170MM STERILE
• 18053340349376: TL PLUS HALF RING 160MM STERILE
• 18053340349369: TL PLUS HALF RING 150MM STERILE
• 18053340349352: TL PLUS HALF RING 140MM STERILE
• 18053340349345: TL PLUS HALF RING 130MM STERILE
• 18053340349338: TL PLUS HALF RING 120MM STERILE
• 18053340349321: TL PLUS HALF RING 100MM STERILE
• 18053340349314: TL PLUS HALF RING 80MM STERILE
• 18053340349307: TL PLUS FULL RING, 240MM STERILE
• 18053340349291: TL PLUS FULL RING, 220MM STERILE
• 18053340349284: TL PLUS FULL RING, 200MM STERILE
• 18053340349277: TL PLUS FULL RING, 180MM STERILE
• 18053340349260: TL PLUS FULL RING, 170MM STERILE
• 18053340349253: TL PLUS FULL RING, 160MM STERILE
• 18053340349246: TL PLUS FULL RING, 150MM STERILE
• 18053340349239: TL PLUS FULL RING, 140MM STERILE
• 18053340349222: TL PLUS FULL RING, 130MM STERILE
• 18053340349215: TL PLUS FULL RING, 120MM STERILE
• 18053340349208: TL PLUS FULL RING 100MM STERILE
• 18053340349192: TL PLUS FULL RING 80MM STERILE
• 18053340349673: TL TRAUMA STRUT STERILE
• 18053340349666: TRUE LOK TRAUMA U-SUPPORT, 180MM STERILE
• 18053340349659: TRUE LOK TRAUMA U-SUPPORT, 160MM STERILE
• 18053340349642: 200 MM DOUBLE ROW FOOT PLATE STERILE
• 18053340349635: TL+ FOOTPLATE 200MM STERILE
• 18053340349628: 180 MM DOUBLE ROW FOOT PLATE STERILE
• 18053340349611: TL+ FOOTPLATE 180MM STERILE
• 18053340349604: TL+ FOOTPLATE 170MM STERILE
• 18053340349598: 160 MM DOUBLE ROW FOOT PLATE STERILE
• 18053340349581: TL+ FOOTPLATE 160MM STERILE
• 18053340349574: 150 MM DOUBLE ROW FOOT PLATE STERILE
• 18053340349567: TL PLUS FOOTPLATE 150MM STERILE
• 18053340349550: TL+ FOOTPLATE 140MM STERILE
• 18053340349543: TL+ FOOTPLATE 130MM STERILE
• 18053340349536: TL PLUS FOOTPLATE 120MM STERILE
• 18052469472880: TRUELOK FOOT LEG ALIGNMENT SUPPORT PACK OF 3 STERILE