Oxiplex

GUDID 10854395004504

Absorbable gel for spine surgery

Fziomed, Inc.

Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

• Primary Device ID: 10854395004504
• NIH Device Record Key: cdf15c75-2683-48c1-b75d-8e4400256b8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxiplex
• Version Model Number: FPC-09010
• Company DUNS: 966718371
• Company Name: Fziomed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com
• Phone: 8055460610
• Email: regulatory@fziomed.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854395004507 [Primary]
GS1	10854395004504 [Package]; Contains: 00854395004507; Package: Secondary (carton) [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN240038

FDA Product Code

• QVL: Absorbable Gel For Intraoperative Use In Spine Surgery

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: 2025-09-19
• Device Publish Date: 2025-09-11