ASSURE

GUDID 00849044090192

ASSURE Translational Cervical Plate 3-Level, 48mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00849044090192
• NIH Device Record Key: be0847cc-4fc8-4fad-bd9d-53ab550ed4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE
• Version Model Number: 117.348
• 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
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter
• Length: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044090192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040721

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

[00849044090192]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-01

On-Brand Devices [ASSURE]

• 00849044093179: ASSURE Cervical Plate 3-Level, 69mm
• 00849044093162: ASSURE Cervical Plate 3-Level, 66mm
• 00849044093155: ASSURE Cervical Plate 3-Level, 63mm
• 00849044093148: ASSURE Cervical Plate 3-Level, 60mm
• 00849044093131: ASSURE Cervical Plate 3-Level, 57mm
• 00849044093124: ASSURE Cervical Plate 3-Level, 54mm
• 00849044093117: ASSURE Cervical Plate 3-Level, 51mm
• 00849044093100: ASSURE Cervical Plate 3-Level, 48mm
• 00849044093094: ASSURE Cervical Plate 3-Level, 45mm
• 00849044093087: ASSURE Cervical Plate 2-Level, 46mm
• 00849044093070: ASSURE Cervical Plate 2-Level, 44mm
• 00849044093063: ASSURE Cervical Plate 2-Level, 42mm
• 00849044093056: ASSURE Cervical Plate 2-Level, 40mm
• 00849044093049: ASSURE Cervical Plate 2-Level, 38mm
• 00849044093032: ASSURE Cervical Plate 2-Level, 36mm
• 00849044093025: ASSURE Cervical Plate 2-Level, 34mm
• 00849044093018: ASSURE Cervical Plate 2-Level, 32mm
• 00849044093001: ASSURE Cervical Plate 2-Level, 30mm
• 00849044092998: ASSURE Cervical Plate 2-Level, 28mm
• 00849044092981: ASSURE Cervical Plate 2-Level, 26mm
• 00849044092974: ASSURE Cervical Plate 1-Level, 26mm
• 00849044092967: ASSURE Cervical Plate 1-Level, 24mm
• 00849044092950: ASSURE Cervical Plate 1-Level, 22mm
• 00849044092943: ASSURE Cervical Plate 1-Level, 20mm
• 00849044092936: ASSURE Cervical Plate 1-Level, 18mm
• 00849044092929: ASSURE Cervical Plate 1-Level, 16mm
• 00849044092912: ASSURE Cervical Plate 1-Level, 14mm
• 00849044090673: Set Screw for Rigid Screws
• 00849044090666: 4.5mm Rigid Screw, Self-Tapping, 20mm
• 00849044090659: 4.5mm Rigid Screw, Self-Tapping, 18mm
• 00849044090642: 4.5mm Rigid Screw, Self-Tapping, 16mm
• 00849044090635: 4.5mm Rigid Screw, Self-Tapping, 14mm
• 00849044090628: 4.5mm Rigid Screw, Self-Tapping, 12mm
• 00849044090611: 4.5mm Rigid Screw, Self-Drilling, 16mm
• 00849044090604: 4.5mm Rigid Screw, Self-Drilling, 14mm
• 00849044090598: 4.5mm Rigid Screw, Self-Drilling, 12mm
• 00849044090581: 4.0mm Rigid Screw, Self-Tapping, 20mm
• 00849044090574: 4.0mm Rigid Screw, Self-Tapping, 18mm
• 00849044090567: 4.0mm Rigid Screw, Self-Tapping, 16mm
• 00849044090550: 4.0mm Rigid Screw, Self-Tapping, 14mm
• 00849044090543: 4.0mm Rigid Screw, Self-Tapping, 12mm
• 00849044090536: 4.0mm Rigid Screw, Self-Tapping, 10mm
• 00849044090529: 4.0mm Rigid Screw, Self-Drilling, 16mm
• 00849044090512: 4.0mm Rigid Screw, Self-Drilling, 14mm
• 00849044090505: 4.0mm Rigid Screw, Self-Drilling, 12mm
• 00849044090499: 4.0mm Rigid Screw, Self-Drilling, 10mm
• 00849044090482: 4.5mm Standard Screw, Self-Tapping, 20mm
• 00849044090475: 4.5mm Standard Screw, Self-Tapping, 18mm
• 00849044090468: 4.0mm Standard Screw, Self-Tapping, 20mm
• 00849044090451: 4.0mm Standard Screw, Self-Tapping, 18mm