MAGNIFY

GUDID 00889095174694

Offset Inserter

GLOBUS MEDICAL, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889095174694
• NIH Device Record Key: 9faef6ec-8def-4b9d-b08b-e08a59525c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNIFY
• Version Model Number: 6126.6101
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095174694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142498

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

[00889095174694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-08

On-Brand Devices [MAGNIFY]

• 00889095174724: Inline Holder
• 00889095174700: Lateral Inserter
• 00889095174694: Offset Inserter
• 00889095174687: Midline Inserter
• 00889095129038: MAGNIFY Expandable ALIF Spacer, 20x25mm, 20°, 18-21mm
• 00889095129021: MAGNIFY Expandable ALIF Spacer, 20x25mm, 20°, 16-19mm
• 00889095129014: MAGNIFY Expandable ALIF Spacer, 20x25mm, 20°, 14-17mm
• 00889095129007: MAGNIFY Expandable ALIF Spacer, 20x25mm, 15°, 18-21mm
• 00889095128994: MAGNIFY Expandable ALIF Spacer, 20x25mm, 15°, 16-19mm
• 00889095128987: MAGNIFY Expandable ALIF Spacer, 20x25mm, 15°, 14-17mm
• 00889095128970: MAGNIFY Expandable ALIF Spacer, 20x25mm, 15°, 12-15mm
• 00889095128963: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 18-21mm
• 00889095128956: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 16-19mm
• 00889095128949: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 14-17mm
• 00889095128932: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 12-15mm
• 00889095128925: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 10-13mm
• 00889095128918: MAGNIFY Expandable ALIF Spacer, 20x25mm, 8°, 8-11mm
• 00889095128901: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 18-21mm
• 00889095128895: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 16-19mm
• 00889095128888: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 14-17mm
• 00889095128871: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 12-15mm
• 00889095128864: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 10-13mm
• 00889095128857: MAGNIFY Expandable ALIF Spacer, 20x25mm, 0°, 8-11mm
• 00889095128840: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 20°, 18-21mm
• 00889095128833: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 20°, 16-20mm
• 00889095128826: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 20°, 14-17mm
• 00889095128819: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 20°, 13-16mm
• 00889095128802: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 15°, 18-21mm
• 00889095128796: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 15°, 16-20mm
• 00889095128789: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 15°, 14-18mm
• 00889095128772: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 15°, 12-15mm
• 00889095128765: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 15°, 11-14mm
• 00889095128758: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 18-21mm
• 00889095128741: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 16-20mm
• 00889095128734: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 14-18mm
• 00889095128727: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 12-16mm
• 00889095128710: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 10-14mm
• 00889095128703: MAGNIFY Expandable ALIF Spacer, 29 x 39mm, 8°, 9-12mm
• 00889095128697: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 18-21mm
• 00889095128680: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 16-20mm
• 00889095128673: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 14-18mm
• 00889095128666: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 12-16mm
• 00889095128659: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 10-14mm
• 00889095128642: MAGNIFY Expandable ALIF Spacer, 29x39mm, 0°, 8-11mm
• 00889095128635: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 20°, 18-21mm
• 00889095128628: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 20°, 16-20mm
• 00889095128611: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 20°, 14-17mm
• 00889095128604: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 20°, 13-16mm
• 00889095128598: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 15°, 18-21mm
• 00889095128581: MAGNIFY Expandable ALIF Spacer, 26 x 34mm, 15°, 16-20mm