i-FACTOR™ Peptide Enhanced Bone Graft

Basic Information

• Brand Name: i-FACTOR™ Peptide Enhanced Bone Graft
• Primary DI: 00850001680028
• Version / Model: 700-050
• Catalog Number: 700-050
• Company Name: Cerapedics Inc.
• Labeler DUNS: 800339702
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-06
• Public Version: 1
• Public Version Date: 2020-04-14
• Public Version Status: New
• Public Device Record Key: 7d9221f0-e71d-4b7c-8785-9bb0fd884461

Device Description

i-FACTOR™ Putty, 5.0 cc Syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOX	Filler, Bone Void, Synthetic Peptide	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46425	Bone matrix implant, animal-derived, bioabsorbable	A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001680028	GS1
Previous	M8517000501	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P140019	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 90 Degrees Fahrenheit