FIBERGRAFT BG Morsels 4600-0060

GUDID 00856879006069

6cc vial of Fibergraft BG Morsels bioactive bone graft substitute

PROSIDYAN, INC.

Bone matrix implant, synthetic

• Primary Device ID: 00856879006069
• NIH Device Record Key: 96e896c7-df4c-4bbe-93aa-0d1da027d784
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBERGRAFT BG Morsels
• Version Model Number: 4600-0050
• Catalog Number: 4600-0060
• Company DUNS: 963425488
• Company Name: PROSIDYAN, 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: true
• 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

Customer Support Contacts

• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com
• Phone: 908-517-3666
• Email: cbagga@prosidyan.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856879006069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151154

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-10
• Device Publish Date: 2017-11-28

On-Brand Devices [FIBERGRAFT BG Morsels]

• 00856879006137: 30cc vial of Fibergraft BG Morsels bioactive bone graft substitute
• 00856879006076: 11cc vial of Fibergraft BG Morsels bioactive bone graft substitute
• 00856879006069: 6cc vial of Fibergraft BG Morsels bioactive bone graft substitute
• 00856879006052: 4cc vial of Fibergraft BG Morsels bioactive bone graft substitute
• 00856879006007: 2cc vial of Fibergraft BG Morsels bioactive bone graft substitute
• 00856879006724: 2cc vial of FIBERGRAFT BG Morsels bioactive bone graft substitute
• 00856879006717: 6cc vial of FIBERGRAFT BG Morsels bioactive bone graft substitute
• 00856879006700: 11cc vial of FIBERGRAFT BG Morsels bioactive bone graft substitute