i-FACTOR Peptide Enhanced Bone Graft 700-010

GUDID M8517000101

i-FACTOR Putty, 1.0cc Syringe

Cerapedics Inc.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device IDM8517000101
NIH Device Record Key2e26af18-22af-4be5-a7dd-729ca4f4f337
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-FACTOR Peptide Enhanced Bone Graft
Version Model Number700-010
Catalog Number700-010
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
HIBCCM8517000101 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-07
Device Publish Date2017-06-26

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

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