Opus Mg Set BVF 712105

GUDID B4477121050

Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

BONE SOLUTIONS, INC.

Bone matrix implant, synthetic, non-antimicrobial
Primary Device IDB4477121050
NIH Device Record Key1215723e-7b8f-48f5-a43b-deb6bcf893a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpus Mg Set BVF
Version Model Number5cc
Catalog Number712105
Company DUNS003506272
Company NameBONE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net
Phone8178098850
Emailcustomerservice@bonesolutions.net

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB4477121050 [Primary]

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 Date2021-10-05
Device Publish Date2021-09-27

On-Brand Devices [Opus Mg Set BVF]

B4477121150Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF
B4477121100Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF
B4477121050Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF
B4477120150Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF
B4477120100Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF
B4477120050Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF

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