nanOss Strata Strip 100x25x8mm

GUDID 00812593022082

nanOss Strata Strip 100x25x8mm

Biogennix, LLC

Synthetic bone graft

• Primary Device ID: 00812593022082
• NIH Device Record Key: 24cf96ed-db60-4805-b2de-ef1d83d3250f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nanOss Strata Strip 100x25x8mm
• Version Model Number: 450108
• Company DUNS: 832270370
• Company Name: Biogennix, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593022082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193487

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2025-08-28
• Device Publish Date: 2025-08-20

Devices Manufactured by Biogennix, LLC

• 00812593022952 - NeoForm Matrix: 2025-09-30 NeoForm Matrix Tapered, 5cc
• 00812593022969 - NeoForm Matrix: 2025-09-30 NeoForm Matrix Medium
• 00812593022976 - NeoForm Matrix: 2025-09-30 NeoFor Matrix Forte, 10cc
• 00812593022983 - NeoForm Matrix: 2025-09-30 NeoForm Matrix Tapered, 10cc
• 00812593022990 - NeoForm Matrix: 2025-09-30 NeoForm Matrix Large
• 00812593023003 - NeoForm Matrix: 2025-09-30 NeoForm Matrix Forte, 20cc
• 00812593022914 - nanOss Strata Moldable: 2025-09-26 nanOss Strata Moldable 1.5cc
• 00812593022921 - nanOss Strata Moldable: 2025-09-26 nanOss Strata Moldable 3cc