OsseoSculpt Moldable, 1.5cc

GUDID 00812593021801

OsseoSculpt Moldable, 1.5cc

Biogennix, LLC

Synthetic bone graft

• Primary Device ID: 00812593021801
• NIH Device Record Key: 910aff44-da3e-46e4-a256-13639ebb6191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsseoSculpt Moldable, 1.5cc
• Version Model Number: 001-OSC
• 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	00812593021801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190371

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: 2025-02-11
• Device Publish Date: 2025-02-03

Devices Manufactured by Biogennix, LLC

• 00812593021931 - Summit Moldable: 2025-03-03 Summit Moldable 1cc
• 00812593021948 - Summit Moldable: 2025-03-03 Summit Moldable 2.5cc
• 00812593021955 - Summit Moldable: 2025-03-03 Summit Moldable 5cc
• 00812593021962 - Summit Moldable: 2025-03-03 Summit Moldable 10cc
• 00812593021979 - Summit Strip: 2025-03-03 Summit Strip 2.5cm x 5xm x 0.8cm
• 00812593021986 - Summit Strip: 2025-03-03 Summit Strip 2.5cm x 10cm x 0.8cm
• 00812593021924 - InteliPowder: 2025-02-19 InteliPowder Surgical Matrix 5mL
• 00812593021894 - CuraSurg Surgical Matrix: 2025-02-18 CuraSurg Surgical Matrix