REVOLVE

GUDID 00849044071504

5.5mm REVOLVE Uniplanar Fracture Screw, 50mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044071504
• NIH Device Record Key: ff7fdc3d-edc2-41b8-8847-403330c42fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVOLVE
• Version Model Number: 585.256
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 50 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044071504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111449

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00849044071504]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-28

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• 00849044072693: 5.5mm REVOLVE Rod, CoCr, 450mm
• 00849044072686: 5.5mm REVOLVE Rod, CoCr, 400mm
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• 00849044072662: 5.5mm REVOLVE Rod, CoCr, 300mm
• 00849044072655: 5.5mm REVOLVE Rod, CoCr, 240mm
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• 00849044072631: 5.5mm REVOLVE Rod, CoCr, 220mm
• 00849044072624: 5.5mm REVOLVE Rod, CoCr, 210mm
• 00849044072617: 5.5mm REVOLVE Rod, CoCr, 200mm
• 00849044072600: 5.5mm REVOLVE Rod, CoCr, 190mm
• 00849044072594: 5.5mm REVOLVE Rod, CoCr, 180mm
• 00849044072587: 5.5mm REVOLVE Rod, CoCr, 170mm
• 00849044072570: 5.5mm REVOLVE Rod, CoCr, 160mm
• 00849044072563: 5.5mm REVOLVE Rod, CoCr, 140mm
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• 00849044072532: 5.5mm REVOLVE Rod, CoCr, 110mm
• 00849044072525: 5.5mm REVOLVE Rod, CoCr, 100mm
• 00849044072518: 5.5mm REVOLVE Rod, CoCr, 90mm
• 00849044072501: 5.5mm REVOLVE Rod, CoCr, 80mm
• 00849044072495: 5.5mm REVOLVE Rod, CoCr, 75mm
• 00849044072488: 5.5mm REVOLVE Rod, CoCr, 70mm
• 00849044072471: 5.5mm REVOLVE Rod, CoCr, 65mm
• 00849044072464: 5.5mm REVOLVE Rod, CoCr, 60mm
• 00849044072457: 5.5mm REVOLVE Rod, CoCr, 55mm
• 00849044072440: 5.5mm REVOLVE Rod, CoCr, 50mm
• 00849044072433: 5.5mm REVOLVE Rod, CoCr, 45mm
• 00849044072426: 5.5mm REVOLVE Rod, CoCr, 40mm
• 00849044072044: 8.5mm REVOLVE Monoaxial Screw, 90mm
• 00849044072037: 8.5mm REVOLVE Monoaxial Screw, 85mm
• 00849044072020: 8.5mm REVOLVE Monoaxial Screw, 80mm
• 00849044072013: 8.5mm REVOLVE Monoaxial Screw, 75mm
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• 00849044071993: 8.5mm REVOLVE Monoaxial Screw, 65mm
• 00849044071986: 8.5mm REVOLVE Monoaxial Screw, 60mm
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