PROTEX

GUDID 00889095034158

7.0mm PROTEX Solid Pedicle Screw 80mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00889095034158
• NIH Device Record Key: ab7a067b-66a3-4b00-ae68-712c75e0ab2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEX
• Version Model Number: 109.073
• 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

• Outer Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095034158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040442

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00889095034158]

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: 2015-11-06

On-Brand Devices [PROTEX]

• 00849044066333: Offset Connector, 35mm
• 00849044066326: Offset Connector, 30mm
• 00849044066319: Offset Connector, 25mm
• 00849044066302: Offset Connector, 20mm
• 00849044066296: Offset Connector, 15mm
• 00849044024708: Adjustable T Connector, 78mm-90mm
• 00849044024692: Adjustable T Connector, 68mm-80mm
• 00849044024685: Adjustable T Connector, 58mm-70mm
• 00849044024678: Adjustable T Connector, 48mm-60mm
• 00849044024661: Adjustable T Connector, 38mm-50mm
• 00849044024654: Adjustable T Connector, 28mm-40mm
• 00849044000078: Parallel Connector, Double, 6.5mm to 6.5mm, Extra Wide
• 00849044000061: Parallel Connector, Double, 6.5mm to 6.5mm, Wide
• 00849044000054: Parallel Connector, Double, 6.5mm to 6.5mm
• 00849044000047: Parallel Connector, 6.5mm to 6.5mm, Extra Wide
• 00849044000030: Parallel Connector, 6.5mm to 6.5mm, Wide
• 00849044000023: Parallel Connector, 6.5mm to 6.5mm
• 00849044000016: In-Line Connector, 6.5mm to 6.5mm
• 00889095035056: 6.00mm Curved Rod, 85mm
• 00889095035049: 6.00mm Curved Rod, 80mm
• 00889095035032: 6.00mm Curved Rod, 75mm
• 00889095035025: 6.00mm Curved Rod, 70mm
• 00889095035018: 6.00mm Curved Rod, 65mm
• 00889095035001: 6.00mm Curved Rod, 60mm
• 00889095034998: 6.00mm Curved Rod, 55mm
• 00889095034981: 6.00mm Curved Rod, 50mm
• 00889095034974: 6.00mm Curved Rod, 45mm
• 00889095034967: 6.00mm Curved Rod, 40mm
• 00889095034950: 6.00mm Curved Rod, 35mm
• 00889095034943: 6.00mm Curved Rod, 150mm
• 00889095034936: 6.00mm Curved Rod, 120mm
• 00889095034929: 6.00mm Curved Rod, 100mm
• 00889095034912: 6.00mm Straight Rod, 85mm
• 00889095034905: 6.00mm Straight Rod, 80mm
• 00889095034899: 6.00mm Straight Rod, 75mm
• 00889095034882: 6.00mm Straight Rod, 70mm
• 00889095034875: 6.00mm Straight Rod, 65mm
• 00889095034868: 6.00mm Straight Rod, 60mm
• 00889095034851: 6.00mm Straight Rod, 55mm
• 00889095034844: 6.00mm Straight Rod, 50mm
• 00889095034837: 6.00mm Straight Rod, 45mm
• 00889095034820: 6.00mm Straight Rod, 40mm
• 00889095034813: 6.00mm Straight Rod, 35mm
• 00889095034806: 6.00mm Straight Rod, 30mm
• 00889095034790: 6.00mm Straight Rod, 600mm
• 00889095034783: 6.00mm Straight Rod, 500mm
• 00889095034776: 6.00mm Straight Rod, 400mm
• 00889095034769: 6.00mm Straight Rod, 300mm
• 00889095034752: 6.00mm Straight Rod, 200mm
• 00889095034745: 6.00mm Straight Rod, 150mm