FDA.report

NovoGro Putty

Primary DI
00863787000409
Brand
NovoGro Putty
Company
OSTEONOVUS, INC.
Model
NGC025
Device description
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
Published
2017-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00863787000409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00863787000409008637870004098637870004090863787000409

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
419-530-5940customerservice@osteonovus.com

Regulatory Flags

DUNS number
079788180
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850063977074OsteoProDM-OPR052025-03-25
00850063977081NovoGro PuttyNANGC052025-03-25
00850063977098NovoGro PuttyNANGC0252025-03-25
00850063977104NovoGro PuttyNANGC102025-03-25
00850063977111NovoGro PuttyNANGC05X2025-03-25
00850063977128NovoGro PuttyNANGC025X2025-03-25
00850063977135NovoGro PuttyNANGC10X2025-03-25
00850063977012RevoGro PuttyRGC052024-04-25
00850063977029RevoGro PuttyRGC102024-04-25
00850063977036RevoGro PuttyRGC05X2024-04-25
00850063977043RevoGro PuttyRGC025X2024-04-25
00850063977050RevoGro PuttyRGC10X2024-04-25
00850063977005RevoGro PuttyRGC0252024-04-24
00863787000430NovoGro PuttyNGC152021-10-28
00863787000478NovoGro PuttyNGC10X2020-12-11
00863787000454NovoGro PuttyNGC025X2018-06-14
00863787000461NovoGro PuttyNGC05X2018-06-14
00863787000416NovoGro PuttyNGC052017-11-06
00863787000423NovoGro PuttyNGC102017-11-06

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