i-FACTOR Peptide Enhanced Bone Graft 700-025

GUDID 00850001680011

i-FACTOR Putty, 2.5cc Syringe

Cerapedics Inc.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00850001680011
NIH Device Record Keyd1dd465a-e2ef-4391-b27c-355320e7597a
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-FACTOR Peptide Enhanced Bone Graft
Version Model Number700-025
Catalog Number700-025
Company DUNS800339702
Company NameCerapedics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(303) 974-6275
Emailcustomerservice@cerapedics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001680011 [Primary]
HIBCCM8517000251 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NOXFiller, Bone Void, Synthetic Peptide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-14
Device Publish Date2020-04-06

On-Brand Devices [i-FACTOR Peptide Enhanced Bone Graft]

M8517000101i-FACTOR Putty, 1.0cc Syringe
00850001680011i-FACTOR Putty, 2.5cc Syringe
00850001680004i-FACTOR Putty, 1.0cc Syringe

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.