OsteoFlo-G 151-012-514

GUDID 03700501806732

Synthetic Bone Substitute Stick 5 x 5 x 10mm (x4)

BIOMATLANTE

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID03700501806732
NIH Device Record Key0f1247d8-2b41-4b95-856f-12f4f0af2ab5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFlo-G
Version Model Number151-012-514
Catalog Number151-012-514
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
GS103700501806732 [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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