SALVINOSS-B

GUDID 00841336112018

SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0 cc 250-1000 microns

Salvin Dental Specialties, Inc.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00841336112018
• NIH Device Record Key: 58c87589-0296-43b5-a595-ecaf93dcc800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SALVINOSS-B
• Version Model Number: SALVINOSS-B-SYR-1.00
• Company DUNS: 113344790
• Company Name: Salvin Dental Specialties, 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

Customer Support Contacts

• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com
• Phone: 714-525-0114
• Email: info@sigmagraft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336112018 [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: 2024-06-04
• Device Publish Date: 2024-05-27

On-Brand Devices [SALVINOSS-B]

• 00841336112018: SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0 cc 250-1000 microns
• 00841336112001: SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5 cc 250-1000 microns
• 00841336111998: SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns
• 00841336111950: SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
• 00841336111943: SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
• 00841336111936: SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
• 00841336111929: SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns