OmegaXP

GUDID 00840916142193

OMEGA XP™ INSERTER ASSY

SPINAL ELEMENTS, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00840916142193
• NIH Device Record Key: de525f96-a341-4963-9a22-4532eeee69bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmegaXP
• Version Model Number: 72-02
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00840916142193 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

[00840916142193]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

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