i-FACTOR Peptide Enhanced Bone Graft

Primary DI
00850001680004
Brand
i-FACTOR Peptide Enhanced Bone Graft
Company
Cerapedics Inc.
Model
700-010
Catalog number
700-010
Device description
i-FACTOR Putty, 1.0cc Syringe
Published
2020-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOXFiller, Bone Void, Synthetic Peptide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOXFiller, Bone Void, Synthetic PeptideUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140019002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140019002I-FACTOR PEPTIDE ENHANCED BONE GRAFTCerapedics, LLC2015-11-03NOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M8517000101PreviousHIBCC0
00850001680004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001680004008500016800048500016800040850001680004

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(303) 974-6275customerservice@cerapedics.com

Regulatory Flags#

DUNS number
800339702
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001680196PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc730-0102025-07-03
00850001680202PearlMatrix P-15 Peptide Enhanced Bone Graft, 2.5cc730-0252025-07-03
00850001680219PearlMatrix P-15 Peptide Enhanced Bone Graft, 5.0cc730-0502025-07-03
00850001680226PearlMatrix P-15 Peptide Enhanced Bone Graft, 10.0cc730-1002025-07-03
00850001680011i-FACTOR Peptide Enhanced Bone Graft700-025700-0252020-04-06
00850001680028i-FACTOR™ Peptide Enhanced Bone Graft700-050700-0502020-04-06
M8517000251i-FACTOR Peptide Enhanced Bone Graft700-025700-0252017-06-26
M8517000101i-FACTOR Peptide Enhanced Bone Graft700-010700-0102017-06-26
M8517000501i-FACTOR™ Peptide Enhanced Bone Graft700-050700-0502016-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001680196PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0ccCerapedics Inc.NOX2025-07-03
00850001680202PearlMatrix P-15 Peptide Enhanced Bone Graft, 2.5ccCerapedics Inc.NOX2025-07-03
00850001680219PearlMatrix P-15 Peptide Enhanced Bone Graft, 5.0ccCerapedics Inc.NOX2025-07-03
00850001680226PearlMatrix P-15 Peptide Enhanced Bone Graft, 10.0ccCerapedics Inc.NOX2025-07-03
00850001680011i-FACTOR Peptide Enhanced Bone GraftCerapedics Inc.NOX2020-04-06
00850001680028i-FACTOR™ Peptide Enhanced Bone GraftCerapedics Inc.NOX2020-04-06
10859477002133AUGMENT® InjectableBiomimetic Therapeutics, LLCNOX2018-06-12
10859477002140AUGMENT® InjectableBiomimetic Therapeutics, LLCNOX2018-06-12
M8517000251i-FACTOR Peptide Enhanced Bone GraftCerapedics Inc.NOX2017-06-26
M8517000101i-FACTOR Peptide Enhanced Bone GraftCerapedics Inc.NOX2017-06-26
10859477002034AUGMENT® Bone GraftBiomimetic Therapeutics, LLCNOX2016-04-05
M8517000501i-FACTOR™ Peptide Enhanced Bone GraftCerapedics Inc.NOX2016-01-12
10859477002041AUGMENT Bone GraftBiomimetic Therapeutics, LLCNOX2015-09-30