OmegaXP

GUDID 00840606163217

OMEGA XP INSERTER - SHORT

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00840606163217
• NIH Device Record Key: bd49fdeb-e013-412e-8200-5061904f0c29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmegaXP
• Version Model Number: 11401-165
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, 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: 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	00840606163217 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

[00840606163217]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-22
• Device Publish Date: 2020-11-10

On-Brand Devices [OmegaXP]

• 00840916148577: ARTICULATING RAKE W/ RATCHET
• 00840916148560: OMEGA XP™ AXIAL BREAKDOWN KNOB
• 00840916148553: LARGE OMEGA XP™ KNOB
• 00840916142193: OMEGA XP™ INSERTER ASSY
• 00840606163576: OMEGA XP™ AXIAL INSERTER - SHORT
• 00840606163569: OMEGA XP™ AXIAL INSERTER
• 00840606163255: OMEGA XP AXIAL INSERTER INNER SHAFT - SHORT
• 00840606163248: OMEGA XP AXIAL INSERTER INNER SHAFT
• 00840606163224: OMEGA XP INSERTER INNER SHAFT
• 00840606163217: OMEGA XP INSERTER - SHORT
• 00840606163200: OMEGA XP INSERTER
• 00840606163194: OMEGA XP INSERTER - SHORT
• 00840606163187: OMEGA XP INSERTER