Omnia Medical Instruments

GUDID 00843511112943

PsiF Mallet with Joint Finder Feature

OMNIA MEDICAL, LLC

Surgical mallet

• Primary Device ID: 00843511112943
• NIH Device Record Key: 0a515973-8640-45ff-a129-9a62407b6aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnia Medical Instruments
• Version Model Number: 22-5P-MAL4
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: 3044134851
• Email: customerservice@omniamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511112943 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [Omnia Medical Instruments]

• 00843511121785: Cervical Tamp
• 00843511104177: 1/4" SQ TCL Adapter handle
• 00843511121280: Bone Access Cannula
• 00843511101374: big handled lenke probe
• 00843511101367: Soft Tissue Sleeve
• 00843511101350: Bullet nose saddle driver
• 00843511122829: Drill Bit
• 00843511123185: 1.4mm x 680 mm Nitinol K-Wire
• 00843511123178: 1.4mm x 520 mm Nitinol K-Wire
• 00843511123161: 1.4mm x 380 mm Nitinol K-Wire
• 00843511121822: Universal Joint Awl
• 00843511122164: TS-TO HANDLE
• 00843511112936: CURETTE, ANGLED CIRCLE
• 00843511112929: CURETTE, CIRCLE
• 00843511112912: CURETTE, LEFT RECTANGLE
• 00843511112905: CURETTE, RIGHT RECTANGLE
• 00843511112943: PsiF Mallet with Joint Finder Feature