OsteoFlo-G 151-012-130

GUDID 03700501806664

Synthetic Bone Substitute Granules 1-2 mm (2x15 cm3)

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID03700501806664
NIH Device Record Key9f20e1a2-7b82-49c9-b152-497c559a6aee
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFlo-G
Version Model Number151-012-130
Catalog Number151-012-130
Company DUNS493710719
Company NameBIOMATLANTE
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103700501806664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-07
Device Publish Date2021-12-30

On-Brand Devices [OsteoFlo-G]

03700501806756Synthetic Bone Substitute Stick 5 x 5 x 20mm (x4)
03700501806749Synthetic Bone Substitute Stick 5 x 5 x 20mm (x2)
03700501806732Synthetic Bone Substitute Stick 5 x 5 x 10mm (x4)
03700501806725Synthetic Bone Substitute Stick 5 x 5 x 10mm (x2)
03700501806718Synthetic Bone Substitute Granules 2-3 mm (2x15 cm3)
03700501806701Synthetic Bone Substitute Granules 2-3 mm (15 cm3)
03700501806695Synthetic Bone Substitute Granules 2-3 mm (10 cm3)
03700501806688Synthetic Bone Substitute Granules 2-3 mm (5 cm3)
03700501806671Synthetic Bone Substitute Granules 2-3 mm (2 cm3)
03700501806664Synthetic Bone Substitute Granules 1-2 mm (2x15 cm3)
03700501806657Synthetic Bone Substitute Granules 1-2 mm (10 cm3)

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