AccessGUDID - DEVICE: i-FACTOR Peptide Enhanced Bone Graft (M8517000101)

GUDID

Device Identifier (DI) Information

Brand Name: i-FACTOR Peptide Enhanced Bone Graft
Version or Model: 700-010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-010
Company Name: Cerapedics Inc.

Primary DI Number: M8517000101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800339702 *Terms of Use

Device Description: i-FACTOR Putty, 1.0cc Syringe

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NOX	Filler, Bone Void, Synthetic Peptide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140019	002

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 32 Degrees Celsius
Storage Environment Temperature: between 59 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e26af18-22af-4be5-a7dd-729ca4f4f337
Public Version Date: April 07, 2020
Public Version Number: 4
DI Record Publish Date: June 26, 2017