Omnia Medical Disc Prep Instruments 16-6P-BT12

GUDID 00843511128197

Boot Spacer, 12mm

OMNIA MEDICAL, LLC

Lumbar interspinous decompression instrument set, reusable

• Primary Device ID: 00843511128197
• NIH Device Record Key: 49377277-6f66-45e9-b2e8-9fce7466b87d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical Disc Prep Instruments
• Version Model Number: 16-6P-BT12
• Catalog Number: 16-6P-BT12
• Company DUNS: 079467378
• Company Name: OMNIA MEDICAL, LLC
• 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: 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
• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511128197 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

[00843511128197]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-05
• Device Publish Date: 2025-01-28

On-Brand Devices [Omnia Medical Disc Prep Instruments]

• 00843511128210: Boot Spacer, 16mm
• 00843511128203: Boot Spacer, 14mm
• 00843511128197: Boot Spacer, 12mm