REVOLVE

GUDID 00889095639469

5.5mm REVOLVE Rod, 310mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00889095639469
• NIH Device Record Key: 947b9263-1317-4b6a-a041-cbad38970a00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVOLVE
• Version Model Number: 185.510
• 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

Device Dimensions

• Length: 310 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095639469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083416

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00889095639469]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-08

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• 00849044089882: 5.5mm REVOLVE Rod, 60mm
• 00849044089875: 5.5mm REVOLVE Rod, 55mm
• 00849044089868: 5.5mm REVOLVE Rod, 50mm
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• 00849044089844: 5.5mm REVOLVE Rod, 40mm
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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
• 00849044072648: 5.5mm REVOLVE Rod, CoCr, 230mm
• 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
• 00849044072556: 5.5mm REVOLVE Rod, CoCr, 130mm
• 00849044072549: 5.5mm REVOLVE Rod, CoCr, 120mm
• 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
• 00849044072006: 8.5mm REVOLVE Monoaxial Screw, 70mm
• 00849044071993: 8.5mm REVOLVE Monoaxial Screw, 65mm
• 00849044071986: 8.5mm REVOLVE Monoaxial Screw, 60mm
• 00849044071979: 8.5mm REVOLVE Monoaxial Screw, 55mm
• 00849044071962: 8.5mm REVOLVE Monoaxial Screw, 50mm
• 00849044071955: 8.5mm REVOLVE Monoaxial Screw, 45mm