X-GEN Granules

GUDID 00813954024844

Anorganic Bone Mineral For Dental Surgery

COLLAGEN MATRIX, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00813954024844
• NIH Device Record Key: 625e4147-f8d0-4868-8ae5-dd358b0b2db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-GEN Granules
• Version Model Number: PMC4010
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954024844 [Primary]

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [X-GEN Granules]

• 00813954024868: Anorganic Bone Mineral For Dental Surgery
• 00813954024851: Anorganic Bone Mineral For Dental Surgery
• 00813954024844: Anorganic Bone Mineral For Dental Surgery
• 00813954024837: Anorganic Bone Mineral For Dental Surgery
• 00813954024820: Anorganic Bone Mineral For Dental Surgery
• 00813954024813: Anorganic Bone Mineral For Dental Surgery