Omnia Medical PSiFDNA 11-5P-DRV1-SS

GUDID 00843511122768

PsiF DNA Driver

OMNIA MEDICAL, LLC

Orthopaedic implant driver

• Primary Device ID: 00843511122768
• NIH Device Record Key: 2fceeac6-3f83-45c1-ac44-cb1c27d61e86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical PSiFDNA
• Version Model Number: 11-5P-DRV1-SS
• Catalog Number: 11-5P-DRV1-SS
• 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: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com
• Phone: 3044164851
• Email: customerservice@omniamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511122768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242431

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

[00843511122768]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Omnia Medical PSiFDNA]

• 00843511128227: PsiF DNA Staple Tower Cap
• 00843511122805: PsiF DNA Instrument Tray
• 00843511122799: PsiF DNA Drill
• 00843511122775: PsiF DNA Impactor
• 00843511122768: PsiF DNA Driver
• 00843511113766: PsiF DNA Staple Tower
• 00843511113759: PsiF DNA Screw, 44mm
• 00843511113742: PsiF DNA Screw, 38mm
• 00843511113735: PsiF DNA Screw, 28mm