GPS Advanced

GUDID 00856879006960

GPS Advanced, Spine

Prosidyan, Inc.

Bone graft delivery kit

• Primary Device ID: 00856879006960
• NIH Device Record Key: 97a6376c-9aa8-4ed6-b12e-269d6f300a71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GPS Advanced
• Version Model Number: 84001000
• Company DUNS: 963425488
• Company Name: Prosidyan, Inc.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856879006960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251648

FDA Product Code

• FMF: Syringe, Piston

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: 2025-09-01
• Device Publish Date: 2025-08-22

Devices Manufactured by Prosidyan, Inc.

• 00856879006960 - GPS Advanced: 2025-09-01GPS Advanced, Spine
• 00856879006960 - GPS Advanced: 2025-09-01 GPS Advanced, Spine
• 00856879006977 - GPS Advanced Cannula: 2025-09-01 GPS Advanced Cannula, 5cc, Spine
• 00856879006908 - FIBERGRAFT Aeridyan Matrix: 2023-04-13 Aeridyan Matrix Bone Graft Substitute, Small, 3cc
• 00856879006915 - FIBERGRAFT Aeridyan Matrix: 2023-04-13 Aeridyan Matrix Bone Graft Substitute, Medium, 6.25cc
• 00856879006922 - FIBERGRAFT Aeridyan Matrix: 2023-04-13 Aeridyan Matrix Bone Graft Substitute, Large, 12.5cc
• 00856879006946 - FIBERGRAFT Aeridyan Matrix: 2023-04-13 Aeridyan Matrix Bone Graft Substitute, X-Large, 20cc
• 00856879006250 - FIBERGRAFT Aeridyan Matrix: 2021-08-12 Aeridyan Matrix Bone Graft Substitute, Large, 12.5cc
• 00856879006281 - FIBERGRAFT Aeridyan Matrix: 2021-08-12 Aeridyan Matrix Bone Graft Substitute, Medium, 6.25cc