OMEGALIF

GUDID 00840916133269

OMEGA XP™ 9MM X 34MM X 11MM 8° C

SPINAL ELEMENTS

Metallic spinal interbody fusion cage

• Primary Device ID: 00840916133269
• NIH Device Record Key: 58be8426-3bf3-4323-b42e-c1fb6469d564
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMEGALIF
• Version Model Number: 72-01-093411-08
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916133269 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-22
• Device Publish Date: 2021-01-14

On-Brand Devices [OMEGALIF]

• 00840916155674: CORING TOOL 12mm
• 00840916155667: CORING TOOL 10mm
• 00840916155650: CORING TOOL 8mm
• 00840916124601: OmegaLIF 9mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11)
• 00840916124717: OmegaLIF 11mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16)
• 00840916124700: OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 11 degree Single Lordosis (11-14)
• 00840916124694: OmegaLIF 9mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16)
• 00840916124687: OmegaLIF 9mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15)
• 00840916124670: OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14)
• 00840916124663: OmegaLIF 9mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14)
• 00840916124656: OmegaLIF 11mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12)
• 00840916124649: OmegaLIF 9mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12)
• 00840916124632: OmegaLIF 11mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15)
• 00840916124625: OmegaLIF 11mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11)
• 00840916124618: OmegaLIF 9mm Wide x 28mm Long x 10mm Collapsed Height x Parallel (10-13)
• 00840916155582: OmegaLIF offset inserter shaft – Long
• 00840916155575: OmegaLIF offset inserter shaft – Short
• 00840916142278: OmegaLIF IRRIGATION DILATOR
• 00840916142261: OmegaLIF AXIAL BREAKDOWN KNOB
• 00840916142254: OmegaLIF Instrument Tray Case
• 00840916142247: OmegaLIF T-HANDLE TRIAL
• 00840916142230: OmegaLIF T-HANDLE INSERTER ASSY
• 00840916142223: OmegaLIF REMOVAL TOOL
• 00840916142216: Omega LLIF Expanding Trial
• 00840916142209: Omega LLIF Expanding Trial
• 00840916133269: OMEGA XP™ 9MM X 34MM X 11MM 8° C
• 00840916133252: OMEGA XP™ 9MM X 34MM X 11MM 3° C
• 00840916133245: OMEGA XP™ 9MM X 34MM X 10MM 3° C
• 00840916133238: OMEGA XP™ 9MM X 34MM X 9MM 3° C
• 00840916133221: OMEGA XP™ 9MM X 34MM X 8MM 0°
• 00840916162160: TORQUE PALM AO HANDLE
• 00840916148546: TORQUE PALM AO INTERNAL ADAPTER