FDA.reportPublic FDA data

AUGMENT® Injectable

Primary DI
10859477002133
Brand
AUGMENT® Injectable
Company
Biomimetic Therapeutics, LLC
Model
K30001510
Catalog number
K30001510
Device description
Injectable Kit
Published
2018-06-12
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859477002133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085947700213310859477002133

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not Freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-238-7117customerservice@wmt.com
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
078774659
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859477002140AUGMENT® InjectableK30003010K300030102018-06-12
10859477002034AUGMENT® Bone GraftK20001510K200015102016-04-05
10859477002041AUGMENT Bone GraftK20003010K200030102015-09-30

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
00850001680004i-FACTOR Peptide Enhanced Bone GraftCerapedics Inc.NOX2020-04-06
00850001680011i-FACTOR Peptide Enhanced Bone GraftCerapedics Inc.NOX2020-04-06
00850001680028i-FACTOR™ Peptide Enhanced Bone GraftCerapedics Inc.NOX2020-04-06
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