PuraXen+

GUDID 00852072007599

PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 0.5g

SIGMAGRAFT, INC.

Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived

• Primary Device ID: 00852072007599
• NIH Device Record Key: 08bf9846-ad53-46b1-8a04-9f90920d38cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraXen+
• Version Model Number: XEN-1000-050
• Company DUNS: 078893672
• Company Name: SIGMAGRAFT, 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: true
• 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	00852072007599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151209

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

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: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [PuraXen+]

• 00852072007650: Puraxen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 0.5cc syringe
• 00852072007643: PuraXen+ Anorganic Cancellous Particulate (0.25 - 1.00mm) - 1.0cc syringe
• 00852072007636: PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.5cc syringe
• 00852072007629: PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.25cc syringe
• 00852072007612: PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 2.0g
• 00852072007605: PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 1.0g
• 00852072007599: PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 0.5g
• 00852072007582: PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 2.0g
• 00852072007575: PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 1.0g
• 00852072007568: PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 0.5g
• 00852072007209: PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.25g