Omnia Medical VBR 06-5V-INS1

GUDID 00843511100407

Omnia Medical VBR, Inserter

OMNIA MEDICAL, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00843511100407
• NIH Device Record Key: 20990b4e-3486-4349-aeb8-15a85df8274a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical VBR
• Version Model Number: 06-5V-INS1
• Catalog Number: 06-5V-INS1
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com
• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511100407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172323

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

[00843511100407]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-02-05

On-Brand Devices [Omnia Medical VBR]

• 08435111000502: Omnia Medical VBR, Short Inserter
• 08435111000403: Omnia Medical VBR, Inserter
• 08435111000519: Omnia Medical VBR, 12mm Tamp
• 00843511101244: 77mm Omnia Medical VBR Trial
• 00843511101237: 75mm Omnia Medical VBR Trial
• 00843511101220: 73mm Omnia Medical VBR Trial
• 00843511101213: 71mm Omnia Medical VBR Trial
• 00843511101206: 69mm Omnia Medical VBR Trial
• 00843511101190: 67mm Omnia Medical VBR Trial
• 00843511101183: 65mm Omnia Medical VBR Trial
• 00843511101176: 63mm Omnia Medical VBR Trial
• 00843511101169: 61mm Omnia Medical VBR Trial
• 00843511101152: 59mm Omnia Medical VBR Trial
• 00843511100926: 13mm Omnia Medical VBR Trial
• 00843511101145: 57mm Omnia Medical VBR Trial
• 00843511101138: 55mm Omnia Medical VBR Trial
• 00843511101121: 53mm Omnia Medical VBR Trial
• 00843511101114: 51mm Omnia Medical VBR Trial
• 00843511101107: 49mm Omnia Medical VBR Trial
• 00843511101091: 47mm Omnia Medical VBR Trial
• 00843511101084: 45mm Omnia Medical VBR Trial
• 00843511101077: 43mm Omnia Medical VBR Trial
• 00843511101060: 41mm Omnia Medical VBR Trial
• 00843511101053: 39mm Omnia Medical VBR Trial
• 00843511101046: 37mm Omnia Medical VBR Trial
• 00843511101039: 35mm Omnia Medical VBR Trial
• 00843511101022: 33mm Omnia Medical VBR Trial
• 00843511101015: 31mm Omnia Medical VBR Trial
• 00843511101008: 29mm Omnia Medical VBR Trial
• 00843511100995: 27mm Omnia Medical VBR Trial
• 00843511100988: 25mm Omnia Medical VBR Trial
• 00843511100971: 23mm Omnia Medical VBR Trial
• 00843511100964: 21mm Omnia Medical VBR Trial
• 00843511100957: 19mm Omnia Medical VBR Trial
• 00843511100940: 17mm Omnia Medical VBR Trial
• 00843511100933: 15mm Omnia Medical VBR Trial
• 00843511100513: Omnia Medical VBR, 12mm Tamp
• 00843511100506: Omnia Medical VBR, Short Inserter
• 00843511100490: Omnia Medical VBR, Case
• 00843511100483: Omnia Medical VBR, 14mm Implant Caddy
• 00843511100476: Omnia Medical VBR, 12mm Implant Caddy
• 00843511100469: Omnia Medical VBR, Endplate Release Tool
• 00843511100452: Omnia Medical VBR, Mallet
• 00843511100445: Omnia Medical VBR, Calipers
• 00843511100438: Omnia Medical VBR, Tamp
• 00843511100421: Omnia Medical VBR, Graft Packing Block
• 00843511100414: Omnia Medical VBR, Trial
• 00843511100407: Omnia Medical VBR, Inserter
• 00843511100391: Omnia Medical VBR, 14mm X 14.5mm X 7.5 Deg End Cap
• 00843511100384: Omnia Medical VBR, 14mm X 14.5mm X 5 Deg End Cap