i-FACTOR™ Peptide Enhanced Bone Graft 700-050

GUDID 00850001680028

i-FACTOR™ Putty, 5.0 cc Syringe

Cerapedics Inc.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00850001680028
• NIH Device Record Key: 7d9221f0-e71d-4b7c-8785-9bb0fd884461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-FACTOR™ Peptide Enhanced Bone Graft
• Version Model Number: 700-050
• Catalog Number: 700-050
• Company DUNS: 800339702
• Company Name: Cerapedics 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: true
• 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

Customer Support Contacts

• Phone: (303) 974-6275
• Email: customerservice@cerapedics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001680028 [Primary]
HIBCC	M8517000501 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140019

FDA Product Code

• NOX: Filler, Bone Void, Synthetic Peptide

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: 2020-04-14
• Device Publish Date: 2020-04-06

Devices Manufactured by Cerapedics Inc.

• 00850001680004 - i-FACTOR Peptide Enhanced Bone Graft: 2020-04-14 i-FACTOR Putty, 1.0cc Syringe
• 00850001680011 - i-FACTOR Peptide Enhanced Bone Graft: 2020-04-14 i-FACTOR Putty, 2.5cc Syringe
• 00850001680028 - i-FACTOR™ Peptide Enhanced Bone Graft: 2020-04-14i-FACTOR™ Putty, 5.0 cc Syringe
• 00850001680028 - i-FACTOR™ Peptide Enhanced Bone Graft: 2020-04-14 i-FACTOR™ Putty, 5.0 cc Syringe
• M8517000101 - i-FACTOR Peptide Enhanced Bone Graft: 2020-04-07 i-FACTOR Putty, 1.0cc Syringe