REVERE

GUDID 00889095002669

5.5mm REVERE 4.5 Polyaxial Screw, 25mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00889095002669
• NIH Device Record Key: 782ac5f1-bc25-4391-9deb-0da7a6e4ee45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVERE
• Version Model Number: 1041.3525
• 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: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095002669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113395

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00889095002669]

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: 2015-10-27

On-Brand Devices [REVERE]

• 00849044089837: 8.5mm REVERE Monoaxial Reduction Screw, 90mm
• 00849044089820: 8.5mm REVERE Monoaxial Reduction Screw, 85mm
• 00849044089813: 8.5mm REVERE Monoaxial Reduction Screw, 80mm
• 00849044089806: 8.5mm REVERE Monoaxial Reduction Screw, 75mm
• 00849044089790: 8.5mm REVERE Monoaxial Reduction Screw, 70mm
• 00849044089783: 8.5mm REVERE Monoaxial Reduction Screw, 65mm
• 00849044089776: 8.5mm REVERE Monoaxial Reduction Screw, 60mm
• 00849044089769: 8.5mm REVERE Monoaxial Reduction Screw, 55mm
• 00849044089752: 8.5mm REVERE Monoaxial Reduction Screw, 50mm
• 00849044089745: 8.5mm REVERE Monoaxial Reduction Screw, 45mm
• 00849044089738: 8.5mm REVERE Monoaxial Reduction Screw, 40mm
• 00849044089721: 8.5mm REVERE Monoaxial Reduction Screw, 35mm
• 00849044089714: 8.5mm REVERE Monoaxial Reduction Screw, 30mm
• 00849044089707: 8.5mm REVERE Reduction Screw, 90mm
• 00849044089691: 8.5mm REVERE Reduction Screw, 85mm
• 00849044089684: 8.5mm REVERE Reduction Screw, 80mm
• 00849044089677: 8.5mm REVERE Reduction Screw, 75mm
• 00849044089660: 8.5mm REVERE Reduction Screw, 70mm
• 00849044089653: 8.5mm REVERE Reduction Screw, 65mm
• 00849044089646: 8.5mm REVERE Reduction Screw, 60mm
• 00849044089639: 8.5mm REVERE Reduction Screw, 55mm
• 00849044089622: 8.5mm REVERE Reduction Screw, 50mm
• 00849044089615: 8.5mm REVERE Reduction Screw, 45mm
• 00849044089608: 8.5mm REVERE Reduction Screw, 40mm
• 00849044089592: 8.5mm REVERE Reduction Screw, 35mm
• 00849044089585: 8.5mm REVERE Reduction Screw, 30mm
• 00849044089578: 8.5mm REVERE Reduction Screw, 25mm
• 00849044068351: SS 5.5mm Closed Offset Connector, Large Rod Stop, 35mm
• 00849044068344: SS 5.5mm Closed Offset Connector, Large Rod Stop, 30mm
• 00849044068337: SS 5.5mm Closed Offset Connector, Large Rod Stop, 25mm
• 00849044068320: SS 5.5mm Closed Offset Connector, Large Rod Stop, 20mm
• 00849044068313: SS 5.5mm Closed Offset Connector, Large Rod Stop, 15mm
• 00849044068306: SS REVERE Trans Iliac Connector, Open, 48mm-57mm
• 00849044068290: SS REVERE Trans Iliac Connector, Open, 40mm-48mm
• 00849044068283: SS REVERE Trans Iliac Connector, Open, 35mm-40mm
• 00849044068276: SS In-Line Connector, 6.5mm to 6.5mm
• 00849044068269: SS REVERE U-Connector 6.35mm, 6.35mm Rod, Left, 200mm Length
• 00849044068252: SS REVERE U-Connector 6.35mm, 6.35mm Rod, Right, 200mm Length
• 00849044068245: SS REVERE Offset Extension Clamp, 6.0mm-6.5mm, 6.35mm Rod, Right, 200mm Length
• 00849044068238: SS REVERE Offset Extension Clamp, 6.0mm-6.5mm, 6.35mm Rod, Left, 200mm Length
• 00849044068221: SS REVERE In-Line Extension Clamp, 6.0mm-6.5mm, 6.35mm Rod, Right, 200mm Length
• 00849044068214: SS REVERE In-Line Extension Clamp, 6.0mm-6.5mm, 6.35mm Rod, Left, 200mm Length
• 00849044068207: SS Parallel Connector Clamp Assembly, 6.5mm to 6.5mm, 18mm Wide
• 00849044068191: SS Rod to Rod Clamp Assembly, 5.5mm to 6.5mm, 18mm Wide
• 00849044068184: Rod to Rod Clamp, 6.5mm to 6.5mm, 18mm Wide, Single
• 00849044068177: Rod to Rod Clamp, 6.5mm to 6.5mm, Single
• 00849044068160: Parallel Connector Clamp, 6.5mm to 6.5mm, 18mm Wide, Single
• 00849044068153: Parallel Connector Clamp, 6.5mm to 6.5mm, Single
• 00849044068146: SS REVERE U-Connector 6.35mm, 5.5mm Rod, Left, 200mm Length
• 00849044068139: SS REVERE U-Connector 6.35mm, 5.5mm Rod, Right, 200mm Length