SalvinOSS Collagen Xenograft and Collagen Bone Graft Material

GUDID 00812337020244

Porcine Anorganic Dental Bone Graft with Bovine Collagen

DSM BIOMEDICAL, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00812337020244
• NIH Device Record Key: ae09577a-8735-421c-a92b-7a08ab7ae883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SalvinOSS Collagen Xenograft and Collagen Bone Graft Material
• Version Model Number: 30069-02
• Company DUNS: 131107757
• Company Name: DSM BIOMEDICAL, 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

• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812337020244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193212

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: 2021-01-25
• Device Publish Date: 2021-01-15

On-Brand Devices [SalvinOSS Collagen Xenograft and Collagen Bone Graft Material]

• 00812337020275: Porcine Anorganic Dental Bone Graft with Bovine Collagen
• 00812337020244: Porcine Anorganic Dental Bone Graft with Bovine Collagen