Golden Spike OM-TLS4540

GUDID 00843511100735

4.5 x 40mm trauma screw

OMNIA MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00843511100735
• NIH Device Record Key: 8470c607-baeb-44f8-9a82-b72994baa7e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Golden Spike
• Version Model Number: OM-TLS4540
• Catalog Number: OM-TLS4540
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843511100735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192096

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00843511100735]

Moist Heat or Steam Sterilization

[00843511100735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-19
• Device Publish Date: 2020-03-11

On-Brand Devices [Golden Spike]

• 00843511100742: 4.5 x 45mm Trauma Screw
• 00843511100735: 4.5 x 40mm trauma screw
• 00843511101343: Golden Spike Tapered Inserter
• 00843511122881: 4.5 x 45mm Threaded Trauma Screw
• 00843511122874: 4.5 x 40mm threaded trauma screw